Preliminary data from late-stage clinical trials of the Covid-19 vaccine developed with the German biotech company BioNTech has been published by US drugmaker Pfizer. The vaccine was found to be more than 90 percent effective. The results are critical as the vaccine is going later this month for a review by the US Food and Drug Administration (FDA) and discussions are closer to reality about the shot obtaining emergency authorisation.
What do the early results say?
The first interim efficacy review by the company shows that the vaccine is capable of demonstrating efficacy against Covid-19. According to the study, the vaccine was “more than” 90% successful in the prevention of Covid-19 among the participants who received a second dose, as opposed to those who received just a placebo.
The company also said that late-stage trial data analysis revealed that there were no significant safety issues.
The findings in the case of Pfizer and BioNTech seem positive, given that the US FDA and many international regulators and health organisations have indicated that a Covid-19 vaccine should be able to protect at least 50 percent of those receiving it.
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?
Not necessarily, however. Out of almost 40,000 volunteers who were injected with the vaccine candidate, the interim results released today were only 94. It is necessary to remember that, based on these efficacy findings alone, we do not apply for the FDA Emergency Use Authorization. Further safety data is also required, and as part of our ongoing clinical trial, we continue to accumulate the safety data, “said Bourla, CEO, Pfizer.”
Will India get access to this vaccine?
Based on existing estimates, companies plan to generate up to 50 million vaccine doses globally in 2020 and up to 1.3 billion doses globally in 2021. Although the Indian government held a “initial meeting” with representatives of the Indian subsidiary of Pfizer in late August after the vaccine’s early phase 1 data had been released, there has since been no significant movement on that front.
The launch of this Covid-19 vaccine in India will rely on whether Pfizer and BioNTech approach India 's drug regulator (Central Drugs Quality Control Organization) for approvals to perform human trials of the candidate here, either on their own or through a collaboration with another Indian vaccine company.
As per the regulatory requirements of India, a vaccine will have to undergo local tests in the country before it could be approved for launch. Read More From Source