UK becomes first country to approve Pfizer/BioNTech coronavirus vaccine
London, Dec 02: United Kingdom became the first country in the world to approve the Pfizer/BioNTech coronavirus vaccine for widespread use.
MHRA, the British regular said that the jab which offers up to 95 per cent protection against COVID-19 illness is safe for roll out. The immunisation could start within days for people in high priority groups.
US has already ordered 40 million doses, which is enough to vaccinate 20 million people with two shots each. The first doses are arriving in the UK in the coming days and 10 million doses should be available soon.
Pfizer and BioNTech said in November that their COVID-19 vaccine was found 95 per cent effective in the final analysis of the Phase 3 trial, including in people aged over 65 years, paving the way for the companies to apply for emergency authorisation from US regulators within days
American pharmaceutical giant Pfizer and its German partner BioNTech said they have concluded phase 3 study of their mRNA-based COVID-19 vaccine candidate BNT162b2, meeting all primary efficacy end points
Based on current projections, the companies expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021
The major announcement comes just two days after leading biotechnology company Moderna said on Monday its virus vaccine had an efficacy rate of 94.5 per cent
Earlier this month, Pfizer and Biontech had said their COVID-19 vaccine candidate was found to be more than 90 per cent effective in preventing COVID-19 in participants
Analysis of the data indicates a vaccine efficacy rate of 95 per cent in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from seven days after the second dose
The companies said the first primary objective analysis is based on 170 cases of COVID-19, of which 162 cases of coronavirus were observed in the placebo group while 8 cases in the BNT162b2 group
Vaccine efficacy was consistent across age, gender, race and ethnicity demographics. The observed efficacy in adults over 65 years of age was over 94 per cent, they said
There were 10 severe cases of COVID-19 observed in the trial, with nine of the cases occurring in the placebo group and one in the BNT162b2 vaccinated group
"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," said Dr Albert Bourla, Pfizer Chairman and CEO
"With hundreds of thousands of people around the globe infected every day, we urgently need to get a safe and effective vaccine to the world," Bourla said
The announcements about the vaccines and their potential availability for use among the general population in the coming weeks and months has offered hope to millions around the world in a year that has seen the COVID-19 pandemic devastate lives and economies and still showing no signs of abating
So far, the coronavirus pandemic has infected more than 55 million people around the world and killed more than 1.3 million people even as governments implemented strict lockdowns and restrictions to slow the spread of the virus that originated in the Chinese city of Wuhan
Pfizer said till date, the Data Monitoring Committee for the study has not reported any serious safety concerns related to the vaccine
A randomised subset of at least 8,000 participants 18 years and older in the phase 2/3 study found that the vaccine was well tolerated and any side effects resolved shortly after vaccination
The sides-effects noticed after the first or second dose was fatigue, and headache.
Further, older adults tended to report fewer and milder side-effects following vaccination
With the safety milestone required by the US Food and Drug Administration (FDA) for Emergency Use Authorisation (EUA) being achieved, Pfizer and BioNTech plan to submit a request within days to the FDA for an EUA based on the totality of safety and efficacy data collected to date, as well as manufacturing data relating to the quality and consistency of the vaccine.