Pfizer and BioNTech are all set to apply for an emergency use authorization request for the COVID-19 vaccine with the FDA and the vaccine is being expected to roll out by the end of this year, after it gets a green signal from the authorities, reads a press release by Pfizer.com.
As per Pfizer and BioNTech’s announcement, the safety milestone has been achieved by the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA). “The companies now plan to submit a request to the FDA for a EUA based on the totality of safety and efficacy data collected along with manufacturing data relating to the quality and consistency of the vaccine” the press release reads. “These data also will be submitted to other regulatory agencies around the world”, it reads further.
This comes after the two companies conducted their mRNA-based COVID-19 vaccine candidate, BNT162b2 resulted in meeting all the primary efficacy endpoints of the study in their ongoing Phase 3 study of final efficacy analysis.
The mRNA COVID-19 vaccine exhibited no serious safety concerns and an efficacy rate of 95 per cent has been seen as effective in protecting individuals from COVID-19. The efficacy rate was consistence across age, gender, race and ethnicity demographics and a 94 per cent efficacy rate was observed in adults over 65 years of age.
“We are grateful that the first global trial to reach the final efficacy analysis mark indicates that a high rate of protection against COVID-19 can be achieved very fast after the first 30 µg dose, underscoring the power of BNT162 in providing early protection,” says Ugur Sahin, M.D., CEO and Co-founder of BioNTech.
The vaccine’s efficacy rate was analyzed in two kinds of participants – without prior SARS-CoV-2 infection (First Primary Objective) and participants with or without prior SARS-CoV-2 infection (Secondary Primary Objective).
162 cases out of 170 cases of COVID-19 were observed in the placebo group versus 8 cases in the BNT162b2 group, in the First Primary Objective analysis as specified in the study protocol. Although the companies say that there are hardly any safety concerns, 2 per cent of volunteers faced headache and fatigue after the vaccine was given. However minimal side effects were seen in the older people. Basing on 10 cases, it has been seen that vaccine is effective against severe COVID.
“If all goes well I could imagine that we gain approval in the second half of December and start deliveries before Christmas, but really only if all goes positively,” Ugur Sahin added.
For a two-dose course of treatment, the vaccine is price tagged to $39 (approx Rs2,900) – this is basing on the supply deal with the US. Pfizer has confirmed that it will not charge other developed countries a lower price for the vaccine than that what the U.S. will pay.
The companies are expected to produce up to 50 million vaccine doses in 2020 globally, and up to 1.3 billion doses by the end of 2021.