Published 13:17 IST, December 2nd 2020
UK approves Pfizer-BioNTech's COVID vaccine for mass rollout, inoculation begins next week
The UK has become the first country in the world to approve Pfizer-BioNtech COVID-19 vaccine candidate for widespread use. Vaccination to begin next week.
The UK on December 2 has become the first country in the world to approve Pfizer-BioNtech COVID-19 vaccine candidate for widespread use. The British regulator, MHRA has said that the mRNA-based vaccine that has shown 95 per cent efficacy, is safe for mass roll out with immunisations in the country starting "early next week" among the high priority groups. Britain has reportedly already placed an order of 40 million doses of Pfizer-BioNTech's COVID-19 vaccine to provide the double-dose immunisation to at least 20 million people.
"The Government has today accepted the recommendation from the independent Medicines and Healthcare products Regulatory Agency (MHRA) to approve Pfizer-BioNTech’s COVID-19 vaccine for use. This follows months of rigorous clinical trials and a thorough analysis of the data by experts at the MHRA who have concluded that the vaccine has met its strict standards of safety, quality and effectiveness," UK government said in a statement.
“The vaccine will be made available across the UK from next week. The NHS has decades of experience in delivering large scale vaccination programmes and will begin putting their extensive preparations into action to provide care and support to all those eligible for vaccination."
As per reports, nearly 10 million doses of the vaccine candidate, BNT162b2 will be available for the UK shortly. The COVID-19 vaccine now approved by the UK is also one of the fastest ever vaccine to become a reality from just a concept as it took only 10 months for a process that could normally take up to a decade. Even though vaccination will begin soon in Britain, people would still be asked to remain cautious and follow the government proposed COVID-19 guidelines.
Announcing the news of Medicines and Healthcare products Regulatory Agency (MHRA) approval, British Secretary of Health and Social Care, Matt Hancock said ‘help is on its way’.
BioNtech-Pfizer file 'formal application' seeking EU approval
UK's approval for mass roll of its vaccine candidate came just a day after Pfizer Inc and BioNTech said on December 2 that they have applied to the European drugs regulator seeking a conditional authorisation of their COVID-19 vaccine candidate BNT162b2 that showed 95 per cent efficacy against the highly-infectious disease. The formal application submission to the EU came after similar steps taken in Britain and the United States as a step closer to launch their vaccine into global markets. BioNTech in a statement said that submission on Tuesday has completed the rolling review process initiated on October 6.
All About Pfizer-BioNTech's Covid Vaccine
Pfizer's vaccine has been demonstrated to be 95% effective against Covid 28 days after the first dose (i.e. 7 days after second dose)
i.e. Dose 1 + 21 days + Dose 2 + 7 days -> 95% efficacy
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.
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.
Updated 13:49 IST, December 2nd 2020