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Summary
- US FDA has commended the expeditious response of Pfizer and BioNTech in Covid-19 vaccine development
- Pfizer-BioNTech co-developed coronavirus vaccine exhibits safety and overwhelmingly high efficacy
In a further advancement in the coronavirus vaccine approval exercise, the United States (US) Food and Drug Administration (FDA) has confirmed that the Covid-19 vaccine being developed by Pfizer Inc (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) ensures highest compliance and safety standards. A constructive revelation over the emergency use authorisation (EUA) of coronavirus vaccine from the US FDA, before the first advisory committee briefing, institutes a strong likelihood of sooner-than-expected approval of the vaccine shot jointly invented by Pfizer and BioNTech.
FDA applauds
The US FDA is slated to hold two advisory committee briefings in the coming weeks on 10 and 17 December. The drug regulator has praised the efforts of Pfizer and BioNTech with regard to the vaccine development program as the pharmaceutical companies have promptly responded to the “urgent and unmet medical need” maintaining the issued guidance.
US FDA on Pfizer-BioNTech Covid-19 vaccine
According to the US FDA findings, the vaccine doses have been “safe and well-tolerated” in the participants over the age of 16 years. The reactogenicity and adverse effects (AE) of the vaccine shots were “milder and less frequent” in the volunteers over the age of 56 years as against the participants below the age of 55 years. Further, the AE profile of participants didn’t suggest any “serious safety concerns,” the drug regulator said in a 92-page advisory committee briefing document.
Need of an immediate vaccine
As per the FDA, an effective vaccine at this critical moment can “impact the trajectory of the pandemic” as there is no broadly effective treatment or prevention that can help in alleviating the adverse impact on public health. With the rising death rate in the United States, a quick Covid-19 vaccine program “can likely prevent many deaths” as a highly effective vaccine may “induce population herd immunity” that will assist in bringing the pandemic under control, the drug regulator said.
The Covid-19 vaccine shot being developed by Pfizer-BioNTech and the available clinical evidence exhibits “strong immune responses and overwhelmingly high vaccine efficacy (VE),” FDA said. Thereby, the vaccine confers protection against Covid-19 (SARS CoV-2) virus among individuals over and above the age of 16 years.
Also Read: Pfizer-BioNTech’s COVID-19 vaccine starts working within ten days of first dose, says FDA
Adverse effects
According to the FDA, the potential risks associated with the vaccine are based on the observations conducted so far following which the administration has prepared an extensive post authorisation plan for the long-term safety surveillance of Pfizer-BioNTech coronavirus vaccine recipients. Other than mild reactogenicity and low incidence of severe or serious events, no “clinically concerning” safety issues have been observed with the vaccine participants. Furthermore, most of the severe cases that came across within the vaccine participants don't exhibit any evidence of vaccine-associated enhanced disease (VAED).
Sign of early approval?
Inferentially, the efficacy, safety and immunogenicity data provided by Pfizer and BioNTech in the EUA application supports a positive assessment of risks and benefits of the vaccine shot developed by the companies. However, the registrational Phase 1/2/3 studies with regard to the coronavirus vaccine development are likely to continue as long as possible in order to obtain additional data that can support a Biologics License Application (BLA) filing in the upcoming days, the US FDA added.
