Govt in Talks with Pfizer Even as Experts Point Out Difficulties in Procuring Vaccine, Say More Data Needed

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The National Expert Group on Vaccine Administration for Covid-19 is in "dialogue with all vaccine manufacturers in India and abroad", the union health secretary said on Tuesday even as the government refrained from divulging details on what the preliminary conversation on procuring vaccines has been.

The government was asked about Pfizer’s RNA vaccine, which the company says has shown efficacy of up to 90 per cent. On Monday, Pfizer announced that its study enrolled 43,538 participants, with 42% having diverse backgrounds, and no serious safety concerns have been observed. "Safety and additional efficacy data continue to be collected," the statement from the company read.

The conclusion was that Pfizer and BioNTech’s vaccine candidate against Covid-19 achieved success in the first interim analysis from the phase-3 study.

While countries like Japan, the UK and US have signed up for doses, India has not. "When we do reach an agreement, we will inform you. Now, discussions are under the non-disclosure agreement," a high-ranking source told News18 on the condition of anonymity.

"We also look at regulatory approvals, awaiting those...Doses, cold chain storage also discussed" in these meetings, said health secretary Rajesh Bhushan, referring to the discussions of the national expert group, not wanting to go into specifics.

Concerns have been raised already about Pfizer’s vaccine which requires storage at -70 degrees. There has to be cautious optimism, is what Dr Gagandeep Kang, known for her pioneering work on an indigenous rotavirus vaccine, indicated.

"This is clinical efficacy, but we do not know about preventing severe disease," she wrote on Twitter. She also said that more data was required. "We do not know about prevention of infection. We do not know about reduction of transmission. We do not know how long protection will last. There is a lot to learn from data that will emerge from the 38K volunteers who have received 2 doses," she tweeted.

"Safety data, 2 months of follow up for median recruited volunteers are expected next week," she wrote. She also raised concerns about the storage temperatures and cost, both areas of concern in India.

"This RNA vaccine needs ultracold storage. Not sure of BioNTech price, but Moderna is 37$ a dose. Which makes these vaccines a stretch for less resourced countries that will find them hard to deliver and expensive," she said in another tweet.

Dr Kang also said, "Vaccines work better early in testing, so we will need to wait and see what the final efficacy is. The study was designed for a point estimate above 60%, but is likely to be way over given how quickly cases may accumulate."

She added, "There are two age strata, so we will wait to see whether there is a difference by age. And then in children younger than 16. Briefly, good news, lots to learn."