After months of deliberation and planning, the Centre has finalised a date on the administration of Covid-19 vaccines. Union Health Secretary Rajesh Bhushan has said that the Centre is likely to rollout Covid-19 vaccines by January 13.
“Based on the feedback of the dry-run, the central government said it is ready to introduce Covid-19 vaccine within 10 days from date of emergency use authorisation (EUA). There are four primary vaccine stores called GMSD located in Karnal, Mumbai, Chennai, and Kolkata. There are also 37 vaccine stores in the country, which stores vaccines in bulk and distributes it,” he said.
The Drug Controller General of India (DCGI) gave Bharat Biotech’s Covaxin and Oxford-AstraZeneca’s Covishield the final approval for EUA vaccine rollout on January 3. However, Bharat Biotech’s vaccine garnered criticism from across the country, as experts claimed that it was approved without any data on Phase III. Experts questioned as to how the vaccine managed to get emergency approval without making the efficacy data public. Some politicians even went on a limb to say that they have no confidence in the two vaccines and will not take the shots.
Based on the feedback of the dry-run, the central government said it is ready to introduce Covid-19 vaccine within 10 days from date of emergency use authorisation.
Union Health Secretary Rajesh Bhushan
However, things got ugly after Serum Institute of India CEO Poonawalla, on January 3, said in a television interview that vaccines other than Pfizer, Moderna, and Oxford-AstraZeneca are “just like water”. Poonawalla’s statement did raise a lot of eyebrows. Many saw this as jibe towards Bharat Biotech. SII is working alongside Oxford-AstraZeneca to produce Covishield in India.
On January 4, Bharat Biotech’s Chairman Dr Krishna Ella hit back at his critics and made a stunning allegation regarding AstraZeneca’s clinical trial. He has said that his firm conducted “200%” honest clinical trials. “We are not just conducting trials in India but in more than 12 countries including the United Kingdom,” Ella told reporters. “Many are spreading false rumours just to unleash critics upon Indian companies. We do not deserve that,” he added.
The Oxford-AstraZeneca vaccine has 60% effects despite them giving 4 grammes of paracetamol to their subjects to suppress side effects. We have not given any paracetamol to our volunteers.
Ella also hit back at Poonawalla for his “vaccines like water” statement without taking his name. “We received backlash despite doing 200% honest clinical trials. Some companies have branded me like water,” Ella said.
The Bharat Biotech Chairman didn’t stop there. He went on to level a considerably severe allegation against AstraZeneca. “The Oxford-AstraZeneca vaccine has 60% effects despite them giving 4 grammes of paracetamol to their subjects to suppress side effects. We have not given any paracetamol to our volunteers. We wanted the adverse effects (fever, pain, etc.) to be reported and even then our side effects are around 15% only,” Ella alleged.
Bharat Biotech is not just conducting trials in India but in more than 12 countries including the United Kingdom.
He made it clear that none of his family members has any associations with any political parties after a lot of opposition leaders came out against the emergency approval of the vaccines. “Since the vaccine is becoming political, I would like to clarify that none of my family members is connected to any political parties,” Ella said. Regarding the missing information, he asked for a week to submit the confirmed data. He also pointed out that his company has manufactured 16 vaccines. “Bharat Biotech is a global company. People should not level such accusations against us especially regarding clinical research,” he said.
Many are saying that I am not transparent with my data. People must have the patience to read our articles published on the internet.
According to Ella, Bharat Biotech is in no way inferior to Pfizer. He told reporters that Pfizer has five publications of vaccine data and so does Bharat Biotech. “We are no way inferior to Pfizer when it comes to the publication of data,” he said. However, Pfizer has also published the data concerning their Phase III trials but the Indian company is yet to do so. Many critics have pointed out that not even the Indian Council of Medical Research has published anything in regards to Bharat Biotech’s Phase III.
Krishna Ella also asked people to read the company’s publication. “I can conclusively say that we are the only company that has extensive research experience and publications. Many are saying that I am not transparent with my data. People must have the patience to read our articles published on the internet,” he said.
The whole fight between the two companies didn’t go over so well with the Centre. Following interventions, SII and Bharat Biotech on Tuesday issued a joint statement pledging to work jointly on the Covid-19 vaccine rollout project.
“Today, Adar Poonawalla and Dr Krishna Ella, jointly on behalf of the companies, have communicated their combined intent to develop, manufacture, and supply Covid-19 vaccines for India and globally,” the statement read. According to them, the most important task is saving lives and livelihoods in India and the world. “Vaccines are a global public health good and they have the power to save lives and accelerate the return to economic normalcy at the earliest,” the statement said.
It added that after both Covid-19 vaccines have been issued emergency use authorisation in India, the focus is on manufacturing, supplying, and distributing, such that the population receives high quality, safe, and efficacious vaccines. “Both companies [SII and Bharat Biotech] are fully engaged in this activity and are considering it our duty to the nation and the world at large to ensure a smooth rollout of vaccines. We are continuing the Covid-19 vaccines’ development activities as planned,” the statement said.
Regardless, the spat between the two top officials has kick-started another row of controversies opening up more doubts in society. One claims that the other’s vaccine is like water and the other claims that their opposition has falsified claims of side effects using other medications. Both allegations are strong and create confusion and panic. This is exacerbated by the lack of documents revealing Covaxin’s Phase III clinical study data. It isn’t about whether or not they can release the data, but why they haven’t until now.
Meanwhile, Oxford-AstraZeneca vaccine has been approved in the United Kingdom, Mexico, Argentina, and India. According to agencies, Switzerland has signed 5.3 million doses of the AstraZeneca vaccine. However, the United States of America and the European Union have indicated that they are unlikely to approve the AstraZeneca vaccine until February 2021.
Meanwhile, as many Health Ministers and experts around the world have stated that the vaccines will be effective against the new strain of coronavirus, a few scientists in the UK are unsure about the claim. According to a scientific advisor to the British government, the experts are not fully confident that Covid-19 vaccine will be effective against the new variant found in South Africa. Reportedly, the new strains in the UK and South Africa are more infectious and they have led to a spike in cases in Britain, leading to a massive lockdown in the United Kingdom.
According to the scientific advisor, British Health Secretary Matt Hancock is worried about the South African variant as they are not confident that the vaccines will be as effective against it as they are against the UK strain. However, vaccine scientists have said that if needed they could tweak the vaccine in six weeks but they haven’t clarified if the tweak will lead to another set of testing or if the existing approval will work. Either way, it opens up more questions than it can answer.