Published 16:53 IST, December 2nd 2020
Pfizer’s COVID-19 vaccine gets approval in UK: Here's everything you need to know
Pfizer's vaccine has been demonstrated to be 95% effective against COVID-19, 28 days after the first dose, i.e., 7 days after the second dose.
Pfizer's vaccine has been demonstrated to be 95% effective against COVID-19, 28 days after the first dose, i.e., 7 days after the second dose. According to the official press release, the Data Monitoring Committee for the study has not reported any serious safety concerns related to the vaccine. The results were published after the conclusion of the phase 3 study which enrolled 43,661 participants. It found 170 confirmed cases of COVID-19, with 162 observed in the placebo group (those who didn't get the vaccine) versus 8 in the vaccine group.
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Dose 1 + 21 days + Dose 2 + 7 days -> 95% efficacy
Dr. Albert Bourla, Pfizer Chairman and CEO, said, “The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic. We continue to move at the speed of science to compile all the data collected thus far and share with regulators around the world”.
Now, as the company announced that the safety milestone required by the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) has been achieved, Pfizer is expected to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021. Pfizer is confident in its vast experience, expertise and existing cold-chain infrastructure to distribute the vaccine around the world.
What to expect?
Pfizer said that 18 years and older in the phase 2/3 study demonstrated that the vaccine was well tolerated. However, the company also noted that that the only Grade 3 (Severe) solicited adverse events greater than or equal to 2% in frequency after the first or second dose was fatigue at 3.8% and headache at 2.0% following dose two. But older adults tended to report fewer and milder solicited adverse events following vaccination.
Ugur Sahin, M.D., CEO and Co-founder of BioNTech, said, “Our objective from the very beginning was to design and develop a vaccine that would generate rapid and potent protection against COVID-19 with a benign tolerability profile across all ages. We believe we have achieved this with our vaccine candidate BNT162b2 in all age groups studied so far and look forward to sharing further details with the regulatory authorities”.
Storage of Pfizer’s vaccine
Pfizer's storage plan is that it has 'developed specially designed, temperature-controlled thermal shippers, utilizing dry ice to maintain temperature conditions of -70°C±10°C. They can be used be as temporary storage units for 15 days by refilling with dry ice.' Essentially, however, the vaccine in its current form needs to be stored at -70°C. Further, each shipper contains a GPS-enabled thermal sensor to track the location and temperature of each vaccine shipment across their pre-set routes leveraging Pfizer’s broad distribution network.
Updated 16:51 IST, December 2nd 2020