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AAP Leader Saurabh Bharadwaj Questions Centre On Allowing Covishield Vaccine In India Despite Ban

May 8, 2024, 12:17 pm

After the worldwide withdrawal of the AstraZeneca COVID-19 vaccine, Aam Aadmi Party leader Saurabh Bharadwaj raised questions on Wednesday regarding the Indian government’s decision to allow the Covishield vaccine, especially in light of most European countries banning it due to side effects.

In a statement posted on X, Saurabh remarked, “When most European Nations had banned the use of Covishield vaccine due to side effects in March 2021, Indian Govt continued the use of this vaccine. Now facing heat from Courts in the UK, they have withdrawn the vaccine world over.”

AstraZeneca withdrew its vaccine after it acknowledged, for the first time in court documents, that it can cause a rare and dangerous side effect, as reported by The Telegraph, a British newspaper.

AstraZeneca stated that the vaccine was being removed from markets for commercial reasons, clarifying that it was no longer being produced or supplied due to updated vaccines combating new variants.

The withdrawal application was filed on March 5 and took effect on May 7. Following the company’s decision to withdraw its “marketing authorisation,” the vaccine can no longer be used in the European Union.

Similar applications will be filed in the UK and other countries in the coming months that have approved the vaccine, known as Vaxzevria.

In recent months, Vaxzevria has faced scrutiny over a very rare side effect causing blood clots and low blood platelet counts. AstraZeneca admitted in court documents filed in the High Court in February that the vaccine “can, in very rare cases, cause TTS.”

AstraZeneca maintained that the decision to withdraw the vaccine was unrelated to the case or the admission of its potential to cause TTS, labeling the timing as a mere coincidence, according to The Telegraph.

Last week, AstraZeneca reaffirmed its commitment to patient safety while emphasizing the overall safety profile of the vaccine.

Despite these rare incidents, the pharmaceutical company reiterated that extensive clinical trial data and real-world evidence consistently support the safety and efficacy of the vaccine. Regulatory agencies worldwide continue to assert that the benefits of vaccination outweigh the risks of such extremely rare side effects.

‘AstraZeneca Accepts Its Covid Vaccine Can Cause Rare Side-Effect’ Before Court

April 30, 2024, 9:29 am

AstraZeneca, a gigantic pharmaceutical company, has finally acknowledged that the Covid vaccine “may, in very rare cases, cause TTS.” This acknowledgment was made public in a court document filed in February and submitted to the High Court.

Expert testimony would be required to determine causation in each particular case, as the business indicated in the filing, stating that TTS can develop even in the absence of immunisation.

In a class action case, AstraZeneca is accused of causing numerous deaths and severe disabilities as a result of the Covid vaccine, which was created in partnership with the University of Oxford.

Certain homes reported a “devastating effect” from the immunisation, according to attorneys.

The British-Swedish multinational pharmaceutical and biotechnology corporation was the target of an original case filed by father-of-two Jamie Scott last year. After receiving the AstraZeneca Covid vaccine in April 2021, Scott claimed in his case to have experienced a “blood clot and a bleed on his brain,” which resulted to serious brain impairment. Scott’s wife was reportedly told by the hospital that he would not make it. These assertions are being contested in court by AstraZeneca.

“We do not accept that TTS is caused by the vaccine at a generic level,” AstraZeneca said in May 2023 in response to Scott’s attorneys.

Low platelet counts and blood clots are the hallmarks of thrombosis with thrombocytopenia syndrome (TTS), often referred to as vaccine-induced immune thrombotic thrombocytopenia (VITT). This highly rare illness is not well understood. While thrombocytopenia is defined as a low platelet count, which often aids in clotting to prevent excessive bleeding, a blood clot in a blood vessel might result in restricted blood flow.

Once the AstraZeneca Covid vaccine was introduced, researchers saw a correlation between VITT and the vaccine, which led them to conclude that there was a link between TTS and the vaccine. AstraZeneca does not seem to see the distinction between VITT and TTS, according to the claimants’ counsel.

Scott’s wife Kate told the Telegraph, “The medical community has long recognised that the immunisation caused VITT. Only AstraZeneca has questioned whether Jamie’s illness was brought on by the injection. After three years of litigation, she sees AstraZeneca’s acknowledgment as a step forward and calls on the government and corporation to move quickly.

She continues, saying, “We have the truth on our side, and we are not going to give up,” demanding an apology from AstraZeneca as well as just recompense for her family and any other impacted parties.

The High Court has received 51 cases from victims and their grieving relatives demanding damages in excess of £100 million.

AstraZeneca also sent their condolences to anyone who have experienced health problems or have lost loved ones. The company underlined the strict regulations set by regulatory bodies to guarantee the safe use of medications, including vaccinations, and stressed that patient safety is their first concern.

Bharat Biotech launches first India-made nasal Covid vaccine iNCOVACC

January 26, 2023, 4:54 pm

On the occasion of the 74th Republic Day Bharat Biotech’s first India-made nasal Covid-19 vaccine, iNCOVACC was launched by Union Health Minister Dr. Mansukh Mandaviya and Union Science and Technology Minister Jitendra Singh on Thursday.

“Bharat Biotech International Limited (BBIL), a global leader in vaccine innovation and developer of vaccines for infectious diseases, today dedicated iNCOVACC® (BBV154) to the nation, the world’s 1st COVID intranasal vaccine for Primary series and Heterologous booster,” release stated.

The statement further reads “Product development and clinical trials for iNCOVACC® were funded in part by the Government of India, through the Department of Biotechnology’s, Covid Suraksha Program.”

Meanwhile, from the Central Drugs Standard Control Organization (CDSCO) it got the approval “for iNCOVACC® to be administered for primary series and as heterologous booster doses”

“Amid growing Covid-19 cases and emerging variants of the highly transmissible virus, a booster dose of the vaccine becomes imperative. iNCOVACC® is now available on CoWIN, and priced at INR 800 for private markets and INR 325 for supplies to Govt of India and State Governments,” the statement read.

“iNCOVACC® is a recombinant replication-deficient adenovirus vectored vaccine with a pre-fusion stabilized spike protein. This vaccine candidate was evaluated in phase I, II, and III clinical trials with successful results,” it stated further.

Moreover, through nasal drops, the vaccine will be formulated to allow intranasal delivery. The vaccine is designed and developed to be cost-effective.

“As needleless vaccination, Bharat Biotech’s iNCOVACC® will be the world’s first such booster dose. India will now have more options when it comes to third doses or precautionary doses,” it said.

“Clinical trials and extensive humoral and cell-mediated responses were conducted to evaluate iNCOVACC® as a primary dose schedule, and as a heterologous booster dose for subjects who have previously received two doses of the two commonly administered Covid-19 vaccines in India. The intranasal vaccine is stable at 2-8°C for easy storage and distribution and has been designed for efficient distribution and easy pain-free administration,” it informed further.

Despite the relatively low demand for Covid vaccines, “Bharat Biotech continued product development in intranasal vaccines, to be well-prepared with platform technologies for future infectious diseases. Bharat Biotech has also initiated the development of variant-specific vaccines for COVID in an attempt to be future-ready”.

“iNCOVACC® was developed in partnership with Washington University, St. Louis, which had designed and developed the recombinant adenoviral vectored construct and evaluated it in preclinical studies for efficacy. Product development related to preclinical safety evaluation, large-scale manufacturing scale-up, formulation, and delivery device development, including human clinical trials, were conducted by Bharat Biotech. The Technology Development Board, Govt of India has been instrumental in debt financing for commercial scale manufacturing facilities,” it said.

However, Dr. Krishna Ella, executive chairman, of Bharat Biotech, said, “With the rollout of iNCOVACC® today, we have achieved our goal of establishing a novel vaccine delivery platform for intranasal delivery. It proves that India can innovate for itself and for the world. We and the country are well prepared for future Covid-19 variants and future infectious diseases. We reaffirm our commitment to India, to lead innovation and develop novel vaccine technologies for combating infectious diseases and public health globally. We have proven these capabilities and expertise time and again with innovative vaccines such as TYPBAR TCV, ROTAVAC, JENVAC, COVAXIN, and others. Bharat Biotech is a leading global developer and manufacturer of vaccines with more than 7 billion doses manufactured to date.”

Suchitra Ella, MD, said, “It is exemplary that India has not only served herself during the pandemic challenges, but also a strong provider to the global platform in distributing vaccines and medicines to over 150 countries. With iNCOVACC® – the world’s 1st intranasal Covid vaccine, we are privileged to defend the nation’s health with global quality and scale.”

iNCOVACC nasal Covid vaccine will cost Rs 800 for private, Rs 325 for govt hospitals

December 27, 2022, 2:19 pm

Bharat Biotech’s nasal COVID-19 vaccine iNCOVACC, has been approved by the center on Tuesday and at Rs 800 the vaccine will be available in private hospitals and government hospitals, it will be available for Rs 325. In the fourth week of January, the vaccine iNCOVACC will be rolled out. As a heterologous booster dose, people can take this vaccine even if they have taken Covishield and Covaxin. However, for above 18 years iNCOVACC will be given and has been approved by the Government of India.

With 6,395 new COVID-19 infections in the last 24 hours, India’s total tally reaches to 44,478,636

September 8, 2022, 11:23 am

India on Thursday was recorded with 6,395 fresh infections of COVID-19. The cases were slightly higher as compared to the day before, i.e., on Wednesday, the total number of cases that came was 5,379. India’s total tally of people infected with COVID-19 is 44,478,636 now.

As per the data received by the Union Health Ministry, the active caseload in the country is 50,342, accounting for 0.11 percent of the total cases. The weekly positivity rate is 1.88 percent, while the daily positivity rate is 1.96 percent.

According to the data, the country’s recovery rate stands at 98.7 percent. A total of 4,39,00,204 people have been recovered so far, out of which 6,614 have been recovered in the last 24 hours.

According to the official data, 88.83 crore samples have been tested since the beginning of the pandemic and 3,25,602 tests have been conducted in the last 24 hours.

Also, India’s vaccination coverage has reached the 214.27 crore-mark, out of which 17.49 crore are precaution (booster) doses. In the last 24 hours, 36,31,977 people have been administered the vaccine doses.

DOCTORS SHARE COVID-19 VACCINE EXPERIENCE

January 19, 2021, 4:00 am

The pan-India massive vaccination drive against Covid-19 began from January 16. Hospitals had prepared for it beforehand, they followed guidelines issued by the Ministry of Health for the vaccination process, trained the team and did dry runs, some hospitals formed Adverse Effects committee, set up Adverse Events Following Immunisation (AEFI) room or made special arrangements to deal with side effects. For a smooth process, each hospital has a pre-vaccination waiting area, vaccination room and observation area. Taking a leap of faith, many healthcare workers including doctors and medical staff from hospitals across the country came forward to get the vaccination dose. They are urging that if given a chance, people should get the vaccine shot. Scientists have worked hard for the vaccine and doctors are leading by example so people should not hesitate to go for the vaccination.

Talking about the vaccination drive, Dr Shreevidya Venkatraman, senior consultant-Internal Medicine, MGM Healthcare, Chennai said, “Covid-19 is here to stay. Covid cases are less but as seen in Europe, the peak is expected in March/April. Vaccination against Covid-19 is our best option. Safety and efficacy of the Covid vaccines have been proven. Mild malaise, fever, and local pain may be expected. So far we have not seen any major hypersensitivity reactions after the administration of the Covid vaccines.” Health professionals including doctors, who were vaccinated at Manipal Hospital, Dwarka, Delhi, said that they are upbeat as the final assault on coronavirus has begun and this will create a strong safeguard against the infectious disease. Dr Pankaj Dhamija, Centre head, Wockhardt Hospital, Mira Road, Mumbai said, “The news of vaccination has certainly given hopes to people. We are proud to be a part of this vaccination drive and committed to working round-the-clock for the betterment of the patients. Coronavirus vaccination will protect people by creating an antibody (immune system) response without getting sick by the virus.”

Doctors and healthcare workers share their first-hand experience with us about receiving the first shot of Covid-19 vaccine:

It is a moment of victory for the war against Coronavirus. I was excited and eagerly waiting for these vaccines to be made available. When this initiation of vaccination news arrived I was upbeat and after going through all the information I readied myself to get vaccinated. The process was well organised and meticulous. I took the first dose of Covisheild vaccine at 10.30 am on Saturday at Indian Spinal Injuries Centre. I was made comfortable and all the information was given. I am doing fine and feeling confident.

— Dr Gururaj Sangothimath, spine surgeon, Indian Spinal Injuries Centre, Vasant Kunj, Delhi

There was certainly an apprehension about taking the vaccine initially in terms of efficacy and reaction. There were misconceptions and after discussions with doctors, everyone came forward to take the vaccine jab. We were made to wait for 30 minutes post the vaccination for any adverse effects after which I experienced mild nausea and gastritis. I was completely fine after an hour of vaccination.

— Dr Prakash K.N., Chief of Medical Services, Columbia Asia Hospital Hebbal, Bengaluru

It feels good to be the first person to be vaccinated in the vaccination site at BLK Super Speciality Hospital. It was just like any other shot that one would have taken. We were really looking forward to this and the process was pretty smooth.

— Dr Sandeep Nayar, Senior Director, Centre for Chest and Respiratory Disease, BLK Super Speciality Hospital, Pusa Road, Delhi

I am glad that I was the first one to get the vaccination at Max Smart Super Speciality Hospital. I did not feel any sign of anxiety or reaction. Everyone should get the vaccine shot and even after the vaccination, people must follow the safety guidelines issued by the government.

— Ashutosh Chaturvedi, Emergency Nursing Head, Max Smart Super Speciality Hospital, Saket, Delhi

I was the first one to get vaccinated at Aakash Healthcare. I was vaccinated at 11:10 am on Saturday and was told to sit for 30 minutes to check if I have got any adverse effects of the vaccine. The government officials assigned were constantly checking with me for any side effects. I had no side effects in my body and I am fine since I got the vaccine shot. I started working after getting vaccination and not experienced any problem. I am having no interruptions due to the vaccine in walking, eating, or working. This is a very appreciable step that the government has taken for healthcare workers.

— Anita Ryder, Support Services Department, Aakash Healthcare Super Specialty Hospital, Dwarka, Delhi

COVID DRY RUN IN HARYANA TO TAKE PLACE ON 7 JANUARY

January 6, 2021, 2:44 am

To ensure successful implementation of the Covid-19 vaccine rollout in Haryana, a ‘dry run’ will be conducted on 7 January 2021 across the state in all districts, on six sites, including three urban and three rural sites, from 11 am to 1 pm.

Haryana Chief Secretary Vijai Vardhan was presiding over the meeting of the State Steering Committee and the State Task Force for the Covid-19 vaccine held with all the Deputy Commissioners through video conferencing here on Tuesday.

During the meeting, the Chief Secretary gave directions regarding the new strain of the Covid-19 virus found in people coming from Britain and said that tracing and testing of such people should be done on priority. Also, contact tracing of these people should be done strictly, he added.

In the meeting, Additional Chief Secretary, Health & Family Welfare Department, Rajeev Arora said that as per the scheme of Union Ministry of Health and Family Welfare, ‘Dry Run’ was conducted on 2 January in Panchkula district. Taking this forward, now on 7 January a ‘dry run’ will be conducted across the state, which aims to practice the entire process of Covid-19 vaccine rollout from beginning to end so that all the challenges in its implementation can be identified.

According to the Central government guidelines, Covid-19 vaccination will start this year with healthcare workers. Health workers will be vaccinated under category-1. Under category-2, frontline workers like municipality and sanitation workers, state and central police forces, civil defence and armed forces and revenue officers will be vaccinated, while people over 50 years of age will be vaccinated under category-3, and those below the age of 50 years who are ill will be vaccinated under category-4.

INDIA IS ALL SET TO ROLL OUT COVID VACCINE BY 13 JANUARY

January 6, 2021, 2:10 am

Days after the Drugs Controller General of India (DCGI) gave approval to two Covid-19 vaccines, the Union Health Ministry on Tuesday said that it is prepared to roll out the coronavirus vaccine by 13 January, paving way for mass vaccination drive in the country.

“We are prepared to roll out Covid-19 vaccines within 10 days of granting emergency use authorisation date, based on dry run feedback,” said Health Secretary Rajesh Bhushan at a press conference. Approval to two vaccines was given on 3 January.

The Drug Controller General of India had, on Sunday, announced approvals to two vaccine—Oxford-AstraZeneca’s Covishield, manufactured by Serum Institute of India, and Bharat Biotech’s Covaxin—for restricted emergency use against Covid-19 infection.

The announcement has come as a major relief for India which has the second highest number of infections in the world, after the US.

Talking about the vaccination process, the Health Secretary said that healthcare workers and frontline workers would not need to register themselves as a beneficiary as their data has been stored in a bulk database. “Healthcare workers and frontline workers would not need to register themselves as a beneficiary as their data in bulk database that has been populated on the Co-WIN vaccine delivery management system in a bulk manner,” said Rajesh Bhushan.

He further said, “When we would come to the population priority group, the provision of registration or editing of data would be used. The system electronically allows session allocation… The process of session allocation would be digital. Whether the beneficiaries have been vaccinated, this will be captured digitally.”

The Health Secretary also emphasised that India’s active Covid-19 cases have now fallen below the 2.5-lakh mark. “The active cases in the country are less than 2.5 lakhs and continue to decline. The positivity rate stood at 1.97 per cent,” he added.

The Health Secretary further said that 44 per cent of active cases are in hospital with moderate or severe symptoms while 56 per cent of cases are very mild or asymptomatic and are in home isolation.

He also revealed how the approved vaccines will travel from manufacturers to the beneficiaries. Addressing a press conference, the health secretary said that the manufacturers will send the vaccine to the Government Medical Store Department depots at Mumbai, Chennai, Kolkata and Karnal in Haryana by air. The vaccine will then travel to 37 state vaccine stores from where it will go to district vaccine stores which will then supply primary health care centres, designated as Covid-19 immunisation centres.

Rajesh Bhushan said that India currently has 29,000 cold chain points where the approved vaccines Covishield and Covaxin can be stored safely.

The vaccine will be first offered to one crore healthcare workers, along with two crore frontline and essential workers and 27 crore elderly, mostly above the age of 50 years with co-morbidities.

On Saturday, Union Health Minister Harsh Vardhan had announced that one crore healthcare workers, along with two crore frontline will get the vaccine for free.

Centre must provide free Covid vaccine to all without discrimination: Balbir Sidhu

January 4, 2021, 2:36 am

Health and family welfare minister of Punjab, Balbir Singh Sidhu on Sunday said that Central Government should provide free of cost Corona vaccine to the state in a stipulated time.

Talking to media persons he said that stringent measures were taken from time to time with view to control the pandemic and now, the Centre cannot backtrack from its duty to supply the Corona vaccine. Sidhu said that about 5364 COVID related unfortunate deaths till date had happened in the state which is about 178 deaths per million, in comparison to Delhi where total 10,577 COVID-19 related deaths took place and their deaths per million rate is quite high at 528. We are in a way better position than other states, he added, saying that Punjab has a recovery rate of 95 % and active cases are declining day-by-day.

Giving details on vaccination preparedness in the state, he said that Punjab is fully prepared for the vaccination drive and state has a capacity of vaccinating 4 lakh persons a day. Elaborating more on this he said that state has established robust storage capacity of 1 crore vaccines in state’s own Cold Chain centres. He stated that Punjab has also achieved more than 95% of routine vaccination of children which is highest in the Country.

Speaking on the occasion, Principal Secretary Health Hussan Lal said that vaccine will be given to about 70 lakh people in the state in phased manner, which includes 1.6 lakh health workers, other frontline workers, people aged above 50 and people with co-morbidities aged below 50. The criteria of the age will be counted as on 1 January, 2021. In the first phase all the 1.6 lakh health care workers will be vaccinated on top priority.

A DECISIVE TURNING POINT: PM MODI ON VACCINE APPROVAL

January 4, 2021, 2:00 am

Prime Minister Narendra Modi on Sunday lauded scientists of the country after the Drug Controller General of India (DCGI) gave approval to Serum Institute of India’s ‘Covishield’ vaccine and Bharat Biotech’s ‘Covaxin’ for emergency use, paving the way for its roll-out and administration to millions.

“A decisive turning point to strengthen a spirited fight! DCGI granting approval to vaccines of @SerumInstIndia and @BharatBiotech accelerates the road to a healthier and COVID-free nation. Congratulations India. Congratulations to our hardworking scientists and innovators,” the Prime Minister said in a series of tweets.

He further said it would make every Indian proud that the two vaccines that have been given emergency use approval are made in India. “This shows the eagerness of our scientific community to fulfil the dream of an Aatmanirbhar Bharat, at the root of which is care and compassion. We reiterate our gratitude to doctors, medical staff, scientists, police personnel, sanitation workers and all Corona warriors for the outstanding work done, that too in adverse circumstances. We will remain eternally grateful to them for saving many lives.”

Prime Minister’s remarks came after Drugs Controller General of India V.G. Somani announced that the CDSCO has decided to accept the recommendations of the Subject Expert Committee and accordingly, vaccine of Serum and Bharat Biotech are being approved for restricted use in emergency situation after adequate examination.

This is a major relief for India which has the second highest number of infections in the world after the US. The Central government plans to vaccinate nearly 30 crore people in the first phase of drive in the next six to eight months.

Meanwhile, Union Health Minister Dr Harsh Vardhan criticised Congress and other Opposition leaders over their comments on Bharat Biotech’s Covaxin, which was cleared for emergency use in the country along with the Oxford-AstraZeneca vaccine manufactured by the Serum Institute of India.

Congress leaders Shashi Tharoor and Jairam Ramesh, and Samajwadi Party chief Akhilesh Yadav had pointed out that Covaxin lacked efficacy data to show the vaccine’s effectiveness before it was approved for emergency use.

“Disgraceful for anyone to politicise such a critical issue. Sh @ShashiTharoor, Sh @yadavakhilesh & Sh @Jairam_Ramesh don’t try to discredit well laid out science-backed protocols followed for approving #COVID19 vaccines. Wake up & realise you are only discrediting yourselves,” Dr Harsh Vardhan tweeted.

The Health Minister said Covaxin is “likely to have similar protective efficacy reported for others”, despite the lack of efficacy data from phase 3 trials.

“Vaccines approved globally based on gene encoding spike proteins have protective efficacy of over 90%. However, Covaxin based on whole inactivated virus has other antigenic epitopes in addition to spike protein. So, it’s likely to have similar protective efficacy reported for others,” the minister said.

“Covaxin is more likely to work against newer variants like N501Y Variant (UK variant) & any other that may arise due to antigenic drift as it contains immunogens (epitopes) from other genes in addition to those from Spike protein. Inactivated virus from NIV also had D614G mutation,” Harsh Vardhan said.

“For those spreading rumours let it be known that EUA for Covaxin is differently conditional—in clinical trial mode EUA for Covaxin is different from Covishield because its use will be in clinical trial mode. All Covaxin recipients to be tracked, monitored as if they’re in trial,” the minister tweeted, referring to emergency use authorisation.

Earlier in the day, Congress leaders had said the government must explain why mandatory protocols and verification of data from phase 3 trials have been dispensed with while granting permission for emergency use of Covaxin.

«Covaxin has not yet had Phase 3 trials. Approval was premature and could be dangerous. @drharshvardhan should please clarify. Its use should be avoided till full trials are over. India can start with the AstraZeneca vaccine in the meantime,» Tharoor tweeted.

Jairam Ramesh too raised concerns and asked the Health Minister to clarify why internationally-accepted protocols on phase 3 trials are being modified. «Bharat Biotech is a first-rate enterprise, but it is puzzling that internationally-accepted protocols relating to phase 3 trials are being modified for Covaxin. Health Minister Harsh Vardhan should clarify,» the senior Congress leader said on Twitter.

Akhilesh Yadav, however, politicised the issue the most when he called it a “BJP vaccine”. He said he would not take the Covid-19 vaccine “at this moment”. “That too given by Bharatiya Janata Party. How can I trust the BJP’s vaccine, no chance? When our government is formed, everyone will get a free vaccine. We cannot take the BJP vaccine. The inoculation programme under the BJP-led regime cannot be trusted,” the former UP CM said.

INDIA’S WAIT OVER, DRUG REGULATOR CALLS COVID-19 VACCINES 110% SAFE

January 4, 2021, 1:56 am

India’s central drug authority, Drugs Controller General of India (DCGI), on Sunday announced the formal approval for the Covid-19 vaccines of Oxford-AstraZeneca, manufactured by the Serum Institute, and Bharat Biotech, saying they would be administered in two dosages each. Drugs Controller General of India V.G. Somani said that the two firms submitted data on their trial runs of the Covid vaccines and both have been granted permission for “restricted use” in emergency situations.

The approval by the DCGI was given on the basis of recommendations submitted by an expert committee of the Central Drugs Standard Control Organisation (CDSCO).

Announcing approval to Serum Institute’s ‘Covishield’ vaccine, Somani said that the vaccine trial was conducted on 23,745 participants and the overall efficacy of the vaccine was found to be more than 70 per cent. “The Indian data was also found to be comparable with overseas clinical studies,” the DCGI said.

“Bharat Biotech’s coronavirus vaccine ‘Covaxin’ is safe and gives a robust immune response,” the DCGI said adding that Covaxin, too, has been approved for restricted use in emergency situations.

Somani also quelled rumours surrounding the Covid-19 vaccines regarding impotency, rubbishing such speculations as “complete nonsense”.

“We will never approve anything if there is even the slightest safety concern. Vaccines are 110 per cent safe. Some side effects like mild fever, pain and allergy are common for every vaccine. It (rumours of impotency) is complete nonsense,” he said.

Earlier on Saturday, Samajwadi Party chief and former Chief Minister of Uttar Pradesh Akhilesh Yadav had said, “Covid-19 vaccine might contain something, which can cause harm. Tomorrow, people will say the vaccine was given to kill or decrease the population. You can even become impotent, anything can happen.”

On 31 December, Prime Minister Narendra Modi had urged people to be careful regarding rumours about vaccines and as responsible citizens refrain from forwarding messages on social media without checking.

“The number of new cases of Covid-19 is decreasing in the country now. We are preparing to run the world’s largest vaccination programme in the next year. In our country, rumours spread quickly. Different people for their personal gains or due to irresponsible behaviour spread various rumours. Maybe rumours will be spread when vaccination begins, some have already begun,” Prime Minister Modi had said.

All India Institute of Medical Sciences (AIIMS) director Dr Randeep Singh Guleria lauded the work done by Indian laboratories in making indigenous vaccines. “The research has been done here and it’s truly from the scratch and it is Indian vaccine. It’s a great moment, especially because unlike past where we had to rely on importing various products like PPE or N95; now we have vaccines which are being manufactured in India itself. We do not have to rely on vaccines coming from outside. They are cost-effective and easy to administer between 2 to 8 degrees Centigrade,” he said.

He also said that a vaccine has to go through various stages of study to make sure that it is safe for use. “It is important to understand that when we look at any vaccine, safety is paramount and therefore a vaccine goes through various stages of studying to make sure that it is safe,” Dr Guleria stated in an interview with ANI.

On some concerns being raised by the Opposition, the AIIMs director said, “All the data are being critically looked at by the regulatory authorities and experts and then only a vaccine is given approval. At multiple levels, the safety is ensured and I do not think we should be concerned.”

There are questions being raised on Covaxin of Bharat Biotech which is yet to go for Phase III trials. Dr Guleria responded, “Even as far as Bharat Biotech vaccine is a concern, it is on a traditional platform which has been used for other vaccines also. It is shown to be safe and they have robust data from Phase I and Phase II trials to show that it’s a safe vaccine.”

IMA TO PARTNER WITH GOVT IN COVID VACCINATION PROGRAMME

January 2, 2021, 4:09 am

New Delhi: The Indian Medical Association (IMA), which has the largest number of registered doctors, has said that it is ready to contribute to the government’s vaccination programme. The IMA is ready to spare its expertise and manpower, right from the district level to the national level, for various expert committees for vaccination.

“Current priority will be to protect healthcare workers and those at high risk to mitigate the public health and economic impacts of the pandemic,” said Dr Jayalal, President of the IMA.

The government has started collecting data for healthcare professionals across the country to be considered for the first phase of the vaccination. The IMA has come forward to help the government with compiling the data by appointing nodal officers at each of its branches. IMA, which has branches even in rural and semi-urban areas, is ready to provide human resources and training and campaign for creating awareness among the public.

Harsh Vardhan reviews preparations ahead of Covid vaccine dry-run in Delhi

January 2, 2021, 4:01 am

Ahead of the dry-run for Covid-19 vaccine in the national capital, Union Health Minister Harsh Vardhan on Friday held a review meeting with the Delhi government officials for the preparations of the mock drill, which is scheduled for 2 January.

The minister was speaking to the Delhi government officials via video-conference. He said the procedure of the vaccination drive is similar to the election preparations. “The procedure of the vaccination drive is the same as the election. In any election, we train people at the booth the same way. We need more manpower so we have to train the people here who can look after the proposed beneficiaries,” the Health Minister said.

“Over 2,000 master trainers at the national level have been trained. Training at state and district level is underway in over 700 districts,” the minister added.

Regarding the target of the vaccination drive, Vardhan said, in this mock drill every detail will be covered.

“Aim of this exercise is to ensure that the minute details are thoroughly researched. Cold storage, temperature, electricity and arrangement of the injections, staff and the challenges, which will come forward during the drive will be studied in the drill,” he said.

Harsh Vardhan said at least two vaccine makers have sent their applications to Drug Controller and experts for approval and the details are being studied thoroughly. Simultaneously we are preparing the medical staff for the drive.

“Doctors, medical staff, frontline workers who will be working under this drive are listed up and the list will be uploaded on Covid-19 platform,” he said.

“The dry-run for coronavirus vaccine will be held at Daryaganj, GTB Hospital and one private hospital in Delhi,” he said. The minister hoped that 2021 will be better than 2020.

4 UK COVID VARIANT CASES DETECTED IN INDIA, TALLY 29

The Central government on Friday said that four more cases of the mutant Covid UK strain have been detected in the country, taking the total tally of such cases to 29 so far. They are kept in physical isolation in health facilities.

Out of these 29 cases, eight have been registered at National Centre for Disease Control in Delhi, two at CSIR Institute of Genomics and Integrative Biology in Delhi, 10 at National Institute of Mental Health and Neuro-Sciences in Bangalore.

Three such cases have been detected at Cellular and Molecular Biology in Hyderabad, five at National Institute of Mental Health and Neuro-Sciences in Bangalore, and one at National Institute of Biomedical Genomics in West Bengal.

On Tuesday, a total of six UK returnees were found to be positive with the new variant genome. These were the first cases to be reported by the country that has the second highest number of cases after the United States.

The British Government had recently announced that the newly identified strain of the virus found in their population is up to 70 per cent more transmissible.

Notably, the new UK variant has already been reported by Denmark, Netherlands, Australia, Italy, Sweden, France, Spain, Switzerland, Germany, Canada, Japan, Lebanon and Singapore.

From November 25 to December 23 midnight, about 33,000 passengers disembarked at various Indian airports from UK. All these passengers are being tracked and subjected by states and UTs to RT-PCR tests.

With agency inputs

Despite Britain’s nod, India in no hurry to approve Covid vaccine, seeks more data

December 31, 2020, 2:55 am

The analysis of the additional data and information submitted by Serum Institute of India (SII) and Bharat Biotech is still being conducted by regulator Central Drug Standard Control Organisation’s (CDSCO) Subject Expert Committee and their next meeting will be held on 1 January 1.

The Subject Expert Committee met on Wednesday to consider the Emergency Use Authorisation (EUA) request of Pfizer, SII and Bharat Biotech Private Ltd.

The meeting was held after Oxford-Astrazeneca vaccine, which is being developed by the SII Pune in India, got a green signal for use in the UK on Wednesday.

Further time was requested on behalf of Pfizer, while the additional data and information presented by the SII and Bharat Biotech was perused and analysed by the SEC.

“The analysis of the additional data and information is going on. SEC will convene again on 1st January 2021 (Friday),” the Centre said in a statement.

America’s Pfizer was the first one to apply for the accelarated approval on 4 December, followed by the SII and Bharat Biotech who applied on 6 and 7 December, respectively.

On 9 December, the Subject Expert Committee had asked the SII and Bharat Biotech to submit more data and information to get approval.

The expert panel had then recommended the SII to submit outcome of the assessment of UK regulator for grant of emergency use approval, the updated safety data of the Phase 2/3 clinical trial and immunogenicity data from the clinical trials in UK and India.

Bharat Biotech was recommended to present the safety and efficacy data from the ongoing Phase 3 clinical trial in the country for further consideration.

Their applications were reviewed again earlier on Wednesday, hours after the UK accepted the recommendation of the Medicines and Healthcare Regulatory Agency (MHRA) to authorise Oxford University-AstraZeneca’s Covid-19 vaccine, named Covishield, for emergency use.

The authorisation was significant for India as the Pune-based SII had tied up with the company to conduct clinical trials and manufacture the vaccine. Besides, Bharat Biotech is developing country’s indigenous coronavirus vaccine—Covaxin—in collaboration with the Indian Council of Medical Research.

The Central government plans to vaccinate nearly 30 crore people in the first phase of drive. It will be offered to one crore healthcare workers, along with 2 crore frontline and essential workers and 27 crore elderly, mostly above the age of 50 years with co-morbidities.

Covishield uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein.

After vaccination, the surface spike protein is produced, priming the immune system to attack the coronavirus if it later infects the body.

The vaccine can be stored, transported and handled at normal refrigerated conditions at two to eight degrees Celsius for at least six months and administered within existing healthcare settings.

Its interim analysis for efficacy showed that the vaccine was 70.4 per cent effective at preventing symptomatic Covid-19 occurring more than 14 days after receiving two doses of the vaccine.

The SII has already made 40 to 50 million doses of the shot. “We have 40-50 million doses of Covishield stockpiled. We will be producing around 300 million doses by July 2021,” its CEO Adar Poonawalla had recently said.

Besides this, Bharat Biotech’s Covaxin is India’s indigenous vaccine and is being developed in collaboration with the ICMR’s National Institute of Virology. The indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) high containment facility. WITH IANS INPUTS

Covid vaccination dry run test held in Gandhinagar

December 30, 2020, 3:17 am

Gandhinagar: A dry run test was conducted for corona vaccination in Gandhinagar city on Tuesday. The dry run test was held at five places decided in Gandhinagar Municipal Corporation area. In the dry run test, 125 beneficiaries were called for vaccination at different places. Through this dry run, all the matters required for vaccination were closely monitored.

Gujarat State Immunisation Officer present at Sector-II Urban Health Center Dr Nayan Jani said that on Monday he had texted the beneficiaries of the corona vaccination and informed them to visit on Tuesday. The beneficiaries came on time at the Urban Health Center at Sector-7.They were then reassured and arranged to stand in social distance. All the beneficiaries who came after that were taken to the vaccination waiting room, from there they were being vaccinated against corona. One by one they were taken to the room where they were given an understanding of the vaccine. In the meanwhile, it was also closely monitored whether the necessary medical facilities were properly arranged in the vaccine room.

All the beneficiaries who were taken to the vaccination room were taken to a separate room after being vaccinated. They were kept there for half-an-hour. They were counselled. What benefits do you and your family get from getting them vaccinated during the council, how do you feel after getting the vaccine? Opinions will be sought on the vaccine and the facility, he said. They will also be sent a message that the vaccination has been successful.

Dr Jani further said that if the beneficiary who has received the message for vaccination cannot come to get the vaccine for any reason, they will be sent the message to come to the next round.

Medical Officer of Gandhinagar Municipal Corporation, Dr Kalpesh Goswami said that dry run for vaccination has been organized at five places in Gandhinagar Municipal Corporation area today. These include Civil Hospital, Gandhinagar, Sector-3 Urban Health Center, Hitech Hospital, Indrada and Sector-3 Primary School. A total of 125 beneficiaries were called for dry run today at five centers.

Dr Goswami added that there are 1,824 frontline warriors in the Gandhinagar Municipal Corporation area, as well as 4,286 healthcare warriors. In addition, details of 41,287 beneficiaries above 50 years of age are available. Along with it, details of 2,483 persons who are less than 50 years old, but are co-morbid are available.

INDIA TO ROLL OUT COVID VACCINE IN JANUARY, 50 MN DOSES READY: SII CEO

December 29, 2020, 2:23 am

New Delhi: Pune-based Serum Institute of India (SII) on Monday expressed hope at the possibility of Covid-19 vaccine—Covishield—receiving the regulatory approval in a “few days”, while emphasising that the company has a massive stockpile 40-50 million doses. It also said that Covishield rollout is expected in January 2021.

“We have 40-50 million doses of Covishield stockpiled. Once we get regulatory approvals in a few days, it will be down to the government to decide how much they can take and how fast. We will be producing around 300 million doses by July 2021,” Serum Institute CEO Adar Poonawalla told a press conference.

He added, “India is a part of COVAX. We will keep giving 50 per cent of everything we make to India and to COVAX at the same time. India has such a large population that we will probably end up giving the majority of those 50 million doses to India first.”

“Initially, in one or two months the offtake will be slow. Once the logistics and everything work out well we can expect the rollout for Covishield in January,” he said.

The drug maker has partnered with global pharma giant AstraZeneca and the Oxford University for making the vaccine and is conducting trials in India. Indian drug regulatory body is looking at the UK’s approval to this vaccine before giving nod for Emergency Use Authorization to its Indian counterpart developed by SII.

Asked whether there is any concern regarding Covid-19 vaccine getting approval, he said, “Regulators are evaluating the data…Lot of people keep raising issues. There are no concerns at all. 92 to 95 per cent vaccine efficiency is there. Emergency use of vaccine may come in the end of December or maybe in January in the UK and we are hoping the same in India as well. We should wait for some good news.”

He, however, mentioned that the first six months of 2021 will see a shortage of vaccines globally. “Nobody can help that. But we will see easing off by August-September 2021 as other vaccine manufactures also being able to supply,” he added.

‘COVAX’ was launched in April by the WHO, Gavi Vaccine Alliance and the Coalition for Epidemic Preparedness Innovations for a solution to accelerate the development and manufacture of Covid-19 vaccines and equitable access to them for people in all countries.

India currently has eight Covid-19 vaccine candidates, including three indigenous vaccines, under different stages of clinical trials which could be ready for authorisation in near future. Serum Institute-Oxford’s Covishield, Bharat Biotech’s Covaxin and Pfizer vaccine are in the fray for emergency use authorisation.

OXFORD VACCINE SHOULD BE EFFECTIVE AGAINST NEW STRAIN: ASTRAZENECA CEO

December 28, 2020, 2:56 am

New Delhi: British pharmaceutical AstraZeneca and the University of Oxford’s Covid-19 vaccine has achieved a “winning formula” for efficacy, Pascal Soriot, CEO of the company said in an interview with a British newspaper. He also added that the vaccine should be effective against the new mutant strain of Covid-19 found in the UK and other parts of the world.

Experts believe that Oxford’s vaccine could become the first one to get emergency use approval from the Drug Controller General of India (DGCI). Others in the fray include Pfizer-BioNTech’s Covid vaccine and ICMR-Bharat Biotech’s Covaxin.

Soriot believes trials will show that AstraZeneca has achieved a vaccine efficacy equal to Pfizer-BioNTech at 95 per cent and Moderna at 94.5 per cent. “We think we have figured out the winning formula and how to get efficacy that, after two doses, is up there with everybody else,” Soriot said in an interview with the Sunday Times newspaper. The CEO added that data would be published at “some point”.

Asked if the Oxford-AstraZeneca vaccine will be effective against the new mutant variant of Covid-19 found in the UK and other parts of the world, he said it “should” be.

The UK government, on 23 December, announced that the developers of the Oxford-AstraZeneca’s COVID-19 vaccine had submitted their data to the Medicines and Healthcare products Regulatory Agency (MHRA). Approval is likely to be granted on Monday to roll out the jab.

The Pfizer-BioNTech’s Covid vaccine was the first one to be authorised for use by the UK’s independent medicines regulator and has been given to 6,00,000 people since last month.

AstraZeneca shot’s efficacy in earlier trials had varying outcomes and showed an average of 70 per cent effectiveness but later jumped to 90 per cent depending on the dosage. However, the vaccine was found to have 90 per cent efficacy on volunteers who received a half-dose first and then a full dose one month later.

Soriot said he was “surprised” by the initial findings. He added, “We would have preferred a simpler set of results.”

AstraZeneca’s vaccine has a logistical advantage over the Pfizer-BioNTech vaccines, as it can be stored, transported and handled at normal refrigerated conditions of between two and eight degrees Celsius for at least six months. On the other hand, Pfizer-BioNTech’s candidate needs to be stored at around -70 Celsius.

ANTIBODIES WILL NOT SAFEGUARD YOU AGAINST COVID RE-INFECTION

December 22, 2020, 8:05 am

About ten months after the first case of Covid-19 was confirmed in Kasaragod, Kerala on 3 February 2020, we still have a lot to learn about the novel coronavirus. While our country’s tally of Covid-19 currently stands at 9.88 million, the concerns about re-infection loom large. Much research is required to understand how long the antibodies developed after a recent Covid-19 infection will protect a person, if at all and are the antibodies even strong enough to fight a re-infection?

The question ‘whether one can be re-infected with Covid-19’ was answered in August 2020 when a 33-year-old man from Hong Kong was infected by the same virus for the second time! This was followed by another case of re-infection of a 25-year-old man from the United States. While these case studies are yet to be peer-reviewed, they bring clarity that re-infection is a reality. After these global developments, it was noted that if SARS-CoV-2 follows the footsteps of other pre-existing coronaviruses, reinfection will be common and will not remain to be a one-off case study.

Now if Covid-19 re-infection becomes the ‘new normal’ will it follow the path of common viruses that give you cold every year as the season changes? If so, one must understand one key difference between the two — seasonal cold is not fatal, Covid-19 can be and have a devastating and long-lasting impact!

Researchers across the globe continue to state that the life and strength of antibodies need to be studied deeply. This would require conducting large studies with a wider range of people who have recently recovered from Covid-19. Closer to home, Indian Council of Medical Research (ICMR) is studying the re-infection episodes among those who have been treated for Covid-19. While more data-driven facts are awaited, it needs to be understood that we cannot take antibodies for granted. They do not make for an ‘immunity passport’ as World Health Organization (WHO) aptly put it.

Now that it has been clarified that there is no fact-based understanding about the ability of our antibodies in fighting off a Covid-19 re-infection, let’s talk about the next phase of beating the virus — vaccination. There’s a need to take a closer look at how the vaccine deployment program will progress, how soon each of us will get the jab, and why it is important to get vaccinated.

Rollout: Ministry of Health and Family Welfare (MoHFW), India, recently released detailed guidelines about mass vaccination that will commence once a regulatory board approved vaccine gets the authorisation.

Priority: While this vaccine may be made available for emergency use, the phase I rollout is aimed at healthcare workers, frontline workers, people over 50 years, and those under 50 years with comorbidities

WHY GET VACCINATED?

Getting a Covid-19 vaccine may prevent you from getting seriously ill even if you do get infected, and it will protect people around you, particularly those at high risk!

Now we know re-infection is real so while we wait for Covid-19 vaccines, let’s continue to safeguard ourselves and our loved ones — it may be a few months before you get the jab if you don’t fall under the aforesaid category. Stay safe, positive, and if you’ve been infected before, don’t take antibodies for granted!

The writer is an infectious disease specialist at Fortis Hospital, Mulund.

HOW COVID-19 VACCINE COULD DEVELOP SO QUICKLY

December 22, 2020, 8:02 am

The charm of history and its enigmatic lesson consist in the fact that, from age to age, nothing changes and yet everything is completely different.

—Aldous Huxley

Early this month, the Pfizer/BioNTech mRNA vaccine was approved within 11 months of the discovery of the Covid-19 virus. Pfizer vaccine is the most rapid vaccine deployment in history, completing all the mandatory stages (the Russian and Chinese vaccines have been approved before Phase III trials).

The history of vaccine development has been chequered and not very encouraging. It took 26 years to develop a vaccine for the human papillomavirus (for cervical cancer) and 25 years for a vaccine for rotavirus (against gastroenteritis). Thirty-five million people have died of AIDS in the last 40 years. Since 1987, thirty vaccine candidates have been tested in human clinical trials but no candidate has cleared the phase III trial till date. Malaria affects 400 million people annually, resulting in two million deaths. Over $100 million is spent annually on malaria vaccine research but there is no vaccine in sight. There is no vaccine against other coronaviruses like SARS and MERS.

How (and why) is it that within 100 days of the discovery of Covid-19, there were 45 vaccines in development? How was it possible that in just 63 days, Moderna could develop a vaccine candidate, do animal trials and then inject in the first volunteer. Today we have over 321 vaccine candidates in various stages of development with 40 vaccine candidates in human clinical trials, nine in phase III trials, and two already approved.

There are broadly four steps of vaccine development and deployment which include understanding the structure of the virus, studying the interactions of the virus in the human body to find a suitable vaccine candidate, clinical trials followed by regulatory approval, and large scale production.

Traditionally, upon identification of a novel virus, the virus had to be taken apart piece by piece to understand its different components. A decade ago, this used to take one to two years. There have been tremendous advancements in genome sequencing in the last decade. As an example, the cost of human genome sequencing has dropped from $100 million in 2001 to just $500 in 2020. With the advanced technologies now available, the scientists in Shanghai could decode the virus in less than 40 hours after receiving the samples. Sequencing the genome of the virus is crucial for developing specific diagnostic tests and identifying potential vaccine candidates. The second step is to identify which elements of the virus trigger an immune response in our body, purify that agent (epitopes), and test it on animals. A decade ago, this process would have taken another one to two years, sometimes more than five years. Various technology breakthroughs along with the use of computational models and Artificial Intelligence have helped shrink these steps to weeks if not days. Moderna vaccine candidate was developed within two days of the publishing of the virus structure.

The last decade has seen the development of computational methods to discover new candidate drugs and vaccines in silico (research conducted by computational models or computer simulations). Machine learning-based models have offered inexpensive and rapid methods for the discovery of effective viral therapies. Artificial Intelligence is increasingly being used in predicting the properties of a potential compound such that only compounds with desired properties are chosen for further development, saving time and money. The third and most crucial step is clinical trials. Like all medicines, vaccines go to clinical trials after they are tested in experimental animals. Based on typical FDA processes, the time for clinical trials could be many years, as the regulatory body requires vaccines to undergo at least three phases of clinical trials before the application for approval is submitted.

Phase I is to assess the safety of the vaccine candidate in a few healthy volunteers (between 20 to 80 volunteers). In phase II, the vaccine is given to a larger number to see if the vaccine has the potential for a protective immune response and to study the candidate vaccine’s safety, proposed doses, schedule of immunisations, and method of delivery (such as oral or nasal or injection), etc.

In phase III, several thousand participants are divided into two groups. One group receives the vaccine, and the other receives a placebo (like a distilled water injection). This phase aims to compare the two groups and establish if the vaccine is effective at preventing the disease. Phase III trial is the most time-consuming step because researchers have to wait for enough participants to be exposed to a virus naturally. Pfizer completed the phase III trial when there were 170 cases of the disease in its trial of around 43,000 volunteers, of which 162 were observed in the placebo group and eight in the vaccine group. Historically, from Phase I clinical trials, around 90% of vaccine candidates fail to make it to final approval, and from Phase III, 25% fail. The investment by a manufacturer in a vaccine candidate typically exceeds $1 billion.

It usually takes one to two years for regulatory approval. Regulatory filing is required after each phase. Due to the pandemic, regulators allowed combining phases I and II trials in some cases. Some regulators (like the UK) have gone for a “rolling review” approval process where they have been studying and auditing the data as it comes instead of starting the review after the complete data is received. Though the regulators are working overtime to evaluate the vaccine candidates, there is a need to develop disruptive technologies and protocols for clinical trials. In terms of the structure of clinical trials, the process of randomised control trials has essentially remained the same since the first such trial of streptomycin in 1946 in the UK. How can we reimagine the clinical trial protocols that imbibe new computational technologies? We also need to adopt an “adaptive trial” framework where the trial can be tweaked as the results come in. How can we find a solution to the paradox of having a vaccine candidate within 42 days which eventually gives 95% efficacy but requires a clinical trial extending ten months while millions die?

Pfizer and Moderna have used a novel mRNA technology for their vaccines which are faster to develop. This new technology does not require a weakened or dead virus for the vaccine. The genetic material mRNA is easy to make in a laboratory, and manufacturing an mRNA vaccine rather than a protein can save months. The mRNA technology only needs the genetic sequence of coronavirus to make a vaccine and no live virus has to be cultured and grown in labs. This new technology is like writing a software upgrade instead of finding new hardware each time.

The Oxford vaccine also uses a scaffold or a ‘carrier virus’ made in a lab to inject the active agent which triggers immunity. The same ‘carrier virus’ is used for various vaccines. Thus we have entered the age of designer and editable vaccines.

The fourth step is rapid manufacturing and deployment. The manufacturing of various Covid vaccine candidates is already underway before clinical trials have concluded. A tremendous amount of risk capital has been available for this to happen. In the US, the White House’s “Operation Warp Speed” has brought together public and private stakeholders to deliver 300 million doses of the Covid-19 vaccine by January 2021. The US government has given grants of over $5 billion for vaccine development. Governments across the world have given out advance purchase contracts for more than six billion doses even before a single vaccine was approved. Together, Pfizer, Moderna, and AstraZeneca will be producing over 1.5 billion doses by June 2021. However, some questions still remain. How long does the immunity to the virus last? Immunity to cold-causing coronaviruses typically lasts only one to two years suggesting that people might need seasonal shots of any Covid-19 vaccine.

To summarise, rapid advances in multiple technologies will lead to even faster development of drugs and vaccines in the future. Today, drug and vaccine development has moved from cell culture and fermentation processes to computational models, data analytics, and AI. The huge amount of money pumped into vaccine research this year will lead to the rapid adoption of new technologies. In the future, we may have a vaccine within three to four months of a new outbreak or a pandemic that may impact the developed world. The global pharma companies and scientific institutions may still not have much interest in the pandemics of the developing world including TB, Malaria, AIDS, etc, and these diseases will continue to kill millions despite the technological advances.

The writer is the founder of NeuroEquilibrium, an Angel Investor and Healthcare thought leader.

GOVT SET TO DECLARE BIG COVID-19 VACCINE NEWS ON 25 DEC: SOURCES

December 21, 2020, 3:09 am

New Delhi: 25 December has been observed as “Good Governance Day” since 2014 to celebrate the birth anniversary of former Prime Minister Atal Bihar Vajpayee. However, this year, if top sources are to be believed, the government is likely to declare some “big news” on the day related to the Covid-19 vaccine.

According to sources, vaccinators across the country have received instructions to be “all set” by 25 December and state trainers for the immunisation drive have been asked to finish their training by Friday. “The state trainers have asked to finish the district level training by 25 December,” sources said.

The Family Welfare Department of Uttar Pradesh has cancelled all leaves of officers and employees of the Health Department till 31 January 2021, stating that their cooperation would be required during that period. The employees whose leaves have been cancelled include doctors, nurses, contract workers and daily wage workers.

Meanwhile, Hindustan Syringes and Medical Devices (HMD) have delivered 289.1 lakh syringes for the nationwide immunisation programme and are targeting to deliver 70.07 crore syringes by April.

“We are on track to finish the shipment of the last few batches against an order of 140 million pieces for COVAX by the end of next week. We have space now to allow us to ramp up our production for the Government of India from 9 lakhs per day to 13.5 lakhs per day of 0.5 ml/0.1ml from the coming week,” said Rajiv Nath, CEO of HMD.

He added that the total dispatches in December, which started on 17 December, for 0.5ml AD syringes as per CMSS’s order amount to 57 lakh in Bareilly, 17.8 lakh for Jhansi, 38.90 lakh for Agra, 26.10 lakh for Kanpur, 58 lakh for Lucknow, 46 lakh for Gorakhpur and 48.1 lakhs for Varanasi. “The total number of syringes delivered till 19 December is 289.1 lakh,” he said.

Dr V.K. Paul, a member (health) of NITI Aayog and the head of the Covid-19 taskforce committee, also said in an exclusive interview, “India is lucky to have so many drug-maker companies. Whenever we have a vaccine, India will prove to be the strongest country to end COVID-19. Our vaccine industry is very strong regarding the development and production of vaccines. India’s vaccines are used in low and middle-income countries as well, which is about 60 percent of the world. We may also get vaccines that are being developed by other countries. We have three companies, amongst which, two are from India and one from another country, which have applied for emergency licensure. Indian companies which have applied for emergency authorisation are Serum Institute of India (SII) and Bharat Biotech, and the other is Pfizer from the US. The DCGI is reviewing their data.”

India has also already manufactured more than 50 million of the AstraZeneca vaccines. The Serum Institute of India (SII) has a tie-up with AstraZeneca, and if the UK grants it authorisation for its Covid-19 vaccine—which is expected to happen by 28-29 December—then the chances of the AstraZeneca vaccine to be authorised by other countries will increase.

INDIA TO PRODUCE 300 MILLION DOSES OF SPUTNIK V NEXT YEAR

December 19, 2020, 3:41 am

India will produce about 300 million doses of Russia’s Sputnik V Covid vaccine next year. Head of the Russian Direct Investment Fund (RDIF), Kirill Dmitriev, said that the production of Sputnik V has begun in other countries, particularly in India, Korea, Brazil, and China, in an interview with Rossiya 24 TV channel.

“In India, we have agreements with four large manufacturers. India will produce about 300 million doses or more of the vaccine for us next year,” he said. India is the largest vaccine maker, vaccine production and pharmaceutical industry in the world.

Sputnik V is already under Phase Two/Three trials in India. Over 22,000 people have been given the first dose and 19,000 people have already received it in the first and second trials.

WILL INDIANS OPT FOR THE VACCINE?

December 16, 2020, 3:55 am

New Delhi: In November 2020, a survey carried out by Local Circles, a community social media platform revealed that Indians are likely to be hesitant of a COVID-19 vaccine. In the survey, 59% of all respondents (8,936 total respondents) said they will not rush to get the vaccine even if it is available by February 2021. Similarly, Accredited Social Health Activist (ASHA) workers conducting door to door survey about the vaccine in Gujrat earlier this month, said people are sceptical about being first in line for an “unknown vaccine”.

However, as per a global survey conducted by the World Economic Forum/IPSOS, 87% of Indians said they would get a vaccine for COVID-19. This figure was much higher than the global average, where overall, 73% of respondents said they would get a COVID-19 vaccine if available.

The intent of vaccination amongst Indians has remained unchanged in 2 rounds of the surveys (August and November 2020). However, for 10 countries, including China, Australia, Spain, and Brazil, the intent of getting a vaccine amongst respondents has reduced.

What are the main reasons for not wanting to get a COVID-19 vaccine? Globally, the side effects are the highest cited concern (34%), followed about concerns about clinical trials moving too fast (33%). Similarly, 34% of Indians also said they are worried about the side-effects, while 16% said they are concerned about the fast-moving trials.

MAKING DEAD VIRUS KILL LIVE ONES: A CASE FOR INACTIVATED COVID-19 VACCINES

December 12, 2020, 4:24 am

Among the vaccines against Covid-19 likely to become available in India in early 2021, Covaxin is an indigenous vaccine, being developed by Bharat Biotech International Limited (BBIL), Hyderabad, in collaboration with the Indian Council of Medical Research (ICMR), New Delhi. The candidate is an inactivated whole virion vaccine.

Most of the vaccine manufacturers based in Western countries are employing ‘smart’ and ‘sexy’ newer technologies to develop vaccines against the SARS CoV-2 virus: be it mRNA technology (Moderna and Pfizer/BioNTech) or genetically engineered adenoviruses (AstraZeneca/Oxford University and Russia’s Gamaleya Research Institute of Epidemiology and Microbiology). However, there are a few manufacturers, notably in India, China and Kazakhstan, which are pursuing an old, trusted and time-tested approach to make a vaccine against the new coronavirus – by using an inactivated/killed virus. First tried successfully in the 1930s, unlike the mRNA or the adenovirus carrier strategy, the inactivated approach has a solid track record. It has to its credit the development of vaccines for diseases like influenza, cholera, plague, rabies, hepatitis A, polio (IPV), etc. The vaccine efficacy of inactivated vaccines has traditionally been between 60% and 70%.

Also Read: We are at the doorstep of getting a coronavirus vaccine: Dr V.K. Paul

The approach of making an inactivated vaccine is remarkably simple. Isolate the virus from a sick/infected person, grow it in the lab, kill/inactivate it, purify, add an adjuvant, and the vaccine is ready! Its storage is also not a problem, as the temperature of a household refrigerator (+2 to +8°C) is all that is necessary. Refrigeration at sub-zero temperatures is not required.

When injected into humans, inactivated vaccines produce immunity. But because the virus is dead, they interact with the immune system differently. The immune response to live and newer vaccines is similar to encountering the virus itself, resulting in the development of humoral (antibodies) and cellular immunity (mediated by T lymphocytes). Inactivated vaccines produce antibodies but show little or no cellular immunity. Since killed or inactivated viruses can’t replicate, they tend to provide a shorter length of protection than live vaccines, and are more likely to require boosters to create long-term immunity. Adjuvants are added to trigger a strong immune response. However, adjuvants can cause more local reactions (such as redness, swelling, and pain at the injection site) and more systemic reactions (such as fever, chills and body aches) than non-adjuvanted vaccines. Traditionally, aluminium-based adjuvants like aluminium hydroxide or aluminium phosphate have been used to trigger strong humoral immunity but with little or no cellular immunity. Newer adjuvants are now available which help to elicit cellular response and make the protection stronger and longer.

The inactivated approach offers some distinct advantages though. The greatest one is that there is no risk of inducing the disease as the virus has been inactivated. The viruses can be rapidly grown in the lab and scaled up using well-established infrastructure and methods. There are very few safety concerns. Inactivated vaccines are easier to store and transport as normal refrigerator temperatures suffice. Because the whole virus is presented to the immune system, it is likely to target not only the spike protein of the SARS-CoV-2, but also the matrix, envelope and nucleoproteins. These vaccines therefore express a wide range of viral antigens. In general, two doses given with an interval of 14 days can give an antibody reaction in four weeks. On the downside, the inactivated vaccines produce mainly humoral immunity (antibodies), invariably require multiple doses, and often require an adjuvant. Correlates of protection afforded by inactivated vaccines are also not known as of now.

China produced the world’s earliest inactivated SARS CoV-2 candidate vaccines. Sinovac Life Sciences, Beijing developed CoronaVac, and the two branches of China National Biotec Group (CNBG) viz. Wuhan Institute of Biological Products and the Beijing Institute of Biological Products affiliated to the China National Pharmaceutical Group (Sinopharm) developed ‘SARS-CoV-2’ vaccine and ‘BBIBP-CorV’ vaccine, respectively. The Bharat Biotech’s vaccine appears to have an advantage over the Chinese vaccines in its composition. Instead of using the traditional aluminium hydroxide as an adjuvant, it is using an adjuvant called Toll Like Receptor 7/8 (TLR-7/8). This is known to enhance not only humoral but also cellular immune responses. The inactivated vaccine formulation containing TLR7/8 agonist adjuvant was used in preclinical/animal studies in Hyderabad. It has shown to induce Th1 biased antibody responses with elevated IgG2a/IgG1 ratio and increased levels of SARS-CoV-2 specific IFN-γ+ CD4 T lymphocyte response.

It is not known whether the Haryana minister received the placebo or the vaccine, since it is a double-blind trial. Even if he received the candidate vaccine, he got only the first dose. The trial vaccine can offer protection only two weeks after the second dose.

The writer is former head of the Epidemiology & Communicable Diseases Division of the Indian Council of Medical Research (ICMR).

AFTER PFIZER & SII, BHARAT BIOTECH SEEKS EMERGENCY USE NOD FOR COVID VACCINE

December 8, 2020, 2:49 am

New Delhi: Hyderabad-based Bharat Biotech on Monday filed an application with the Drugs Controller General of India (DCGI) for emergency use authorisation of its Covid-19 vaccine—Covaxin.

The application was filed before the apex drug regulator on Monday evening, a company source told news agency IANS on the condition of anonymity.

After Pfizer and the Serum Institute of India, Bharat Biotech has become the third pharmaceutical in India to seek emergency use authorisation for its Covid vaccine in India.

Covaxin, India’s indigenous Covid-19 vaccine by Bharat Biotech, is developed in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).

Emergency use authorisation is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies.

Covaxin is an indigenous, inactivated vaccine being developed and manufactured at Bharat Biotech’s Bio-Safety Level 3 bio containment facility. It is a highly purified and inactivated vaccine, manufactured in a vero cell manufacturing platform.

On 16 November, Bharat Biotech had announced commencement of Phase III trials of the vaccine. The trials involved 26,000 volunteers across India, conducted in partnership with ICMR. It is the largest clinical trial conducted for a Covid-19 vaccine in India.

Covaxin has been evaluated in 1,000 subjects in Phase I and Phase II clinical trials, with promising safety and immunogenicity data.

On 28 November, Prime Minister Narendra Modi had visited the Bharat Biotech facility in Hyderabad to review vaccine development. “At the Bharat Biotech facility in Hyderabad, was briefed about their indigenous Covid-19 vaccine. Congratulated the scientists for their progress in the trials so far. Their team is closely working with ICMR to facilitate speedy progress,” the PM had tweeted.

On Saturday, a controversy had erupted around Covaxin after Haryana Health Minister Anil Vij, who was administered the first dose of Covaxin last month, tested positive for Covid-19.

This prompted the company to clarify, “Covaxin clinical trials are based on a 2-dose schedule, given 28 days apart. The vaccine efficacy will be determined 14 days post the 2nd dose. Covaxin has been designed to be efficacious when subjects receive both doses and post the 14 days period after the 2nd dose.”

“The antibodies against the infection build up in a human being only after a specific number of days pass after the second dose of the vaccine is taken. This is a two-dose vaccine. The minister in question has taken only one dose of the vaccine,” the Union Health Ministry said on the matter.

The Haryana health minister too said antibodies start to develop after administration of the second dose, which is given 28 days after the first shot, and there is no protection during this period. The 67-year-old minister was given the first shot on 20 November.