Nearly halfway into November, US drugmaker Pfizer has released preliminary data from late stage human trials of the Covid-19 vaccine it developed with German biotech firm BioNTech. The findings are critical as the vaccine is headed for a review by the US Food and Drug Administration later this month, and talks of the shot receiving emergency authorisation have been doing the rounds:
What do the early Pfizer Covid-19 vaccine results say?
The company’s first interim efficacy analysis signals that the vaccine is able to demonstrate an effectiveness against Covid-19. According to the findings, the vaccine was “more than” 90 per cent effective in preventing Covid-19 among vaccinated participants who had never contracted the contagious infection on the seventh day after they had received the second dose. This was in comparison to participants who had only received a placebo.
Considering that the USFDA as well as several international regulators and health organisations have suggested that a Covid-19 vaccine has to be able to protect at least 50 per cent of those receiving it, the findings in Pfizer and BioNTech’s case seem promising.
“The results demonstrate that our mRNA-based vaccine can help prevent COVID-19 in the majority of people who receive it. This means we are one step closer to potentially providing people around the world with a much-needed breakthrough to help bring an end to this global pandemic,” said Albert Bourla, CEO, Pfizer, in a statement upon the release of the results.
“This is a first but critical step as we continue our work to deliver a safe and effective vaccine,” he added.
The phase 3 trials of this vaccine candidate–BNT162b2–began on July 27 and has so far enrolled 43,538 participants, 38,955 of whom had received a second dose as of November 8.
Does this mean the vaccine will receive emergency approval in the US? What are the caveats?
Not necessarily. The interim results released today were of only 94 out of nearly 40,000 volunteers that were injected with the vaccine candidate.
“It’s important to note that we cannot apply for FDA Emergency Use Authorization based on these efficacy results alone. More data on safety is also needed, and we are continuing to accumulate that safety data as part of our ongoing clinical study,” said Bourla.
Pfizer and BioNTech are currently accumulating this additional safety data and estimate that it will take until the third week of November for the company to make available two months’ worth of safety data following the second and final dose of the vaccine. Since this is the amount of safety data specified by the US FDA in its guidance for potential Emergency Use Authorisation, it is likely that the firms will be able to approach the regulator for emergency approval then.
Will India get access to the Pfizer vaccine?
So far, no. The launch of this Covid-19 vaccine would depend on whether Pfizer and BioNTech, either on their own or through a partnership with another Indian vaccine firm, approach India’s drug regulator (Central Drugs Standard Control Organisation) for approvals to conduct human trials of the candidate here. It may also make a difference if the Indian government is in talks with the firms to facilitate access to this vaccine in the country. However, so far, the government here has not acknowledged that any such attempt is underway.
India is focussed on five other Covid-19 vaccine candidates being tested by Serum Institute of India, Bharat Biotech, Zydus Cadila, Dr Reddy’s Laboratories and Biological E.