Pfizer’s Covid-19 vaccine: All you need to know in 10 points2 min read . Updated: 19 Nov 2020, 01:34 PM IST
- After more data indicate BioNTech-Pfizer vaccines are working safely, the global drugmakers plan to apply for emergency authorisation from US Food and Drug Administration within days
'If all goes well', BioNTech-Pfizer vaccines could be available as early as Christmas this year, says BioNTech Chief Executive Ugur Sahin.
The US Food and Drug Administration might grant emergency-use approval towards the end of the first half of December or early in the second half, the BioNTech Chief Executive added.
Speaking to Reuters TV, Ugur Sahin said, "If all goes well I could imagine that we gain approval (from US FDA) in the second half of December and start deliveries before Christmas, but really only if all goes positively."
Meanwhile, as the race for Covid-19 vaccine heats up, the World Health Organization's emergencies director warned saying that vaccines would not arrive in time to defeat the second wave of the novel coronavirus pandemic.
Here is your 10-point cheat-sheet to this big story:
1) American pharmaceutical company Pfizer Inc and its German partnet BioNTech said that their coronavirus vaccine was found to be 95% effective in a late-stage trial, including in people aged over 65 years.
2) In Phase 3 trial, the vaccine protected people, starting from 18 years of age to older against the deadly virus with at least one symptom. Out of 170 study subjects who developed Covid-19 with a symptom, 162 were on placebo, and only eight received the vaccine. And nine out of the 10 severe cases of coronavirus were volunteers who took a placebo. The results were consistent across ages 18 years to 85 years, races and ethnic groups, reports The Wall Street Journal.
3) This has paved the way for the global drugmakers to apply for emergency authorisation from US Food and Drug Administration within days, after more data indicate it is working safely.
4) Pfizer and BioNTech also said they have concluded phase 3 study of their mRNA-based coronavirus vaccine candidate BNT162b2, meeting all primary efficacy endpoints.
5) On vaccine safety, the drug makers said that two-dose vaccine was well-tolerated in 8,000 study subjects. In the group, the most frequent severe side effect was fatigue in 3.8% of the volunteers who fell ill, while 2% of the group reported headaches.
6) However, this is not enough to establish the safety of the Covid-19 vaccine. Serious side effects tend to surface within six weeks of inoculation, so the US FDA requested researchers wait to see how half of a study’s subjects fared for two months after their second dose.
7) Pfizer and BioNTech say they have that data, and are analysing it. They are yet to reveal the fuller safety data.
8) The Covid vaccine is on track to be cleared as early as December, so long as it proves to be safe, and distribution could start soon after.
9) Based on current projections, the firm expects to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021.
10) This means only the highest-risk groups, such as front-line health-care workers, could be inoculated this year. Many more doses would be needed to cover the U.S. and global population.
Meanwhile, shares of Pfizer Ltd rose nearly 4% in early trade today after the firm announced that the virus vaccine developed in partnership with BioNTech was found 95% effective in the final analysis of the Phase 3 trial.
The stock surged by 3.83% to ₹5,098 on the BSE.
Similarly, on NSE, shares of Pfizer Ltd rose by 3.85% to ₹5,096.20.
With agency inputs