Pfizer, BioNTech COVID-19 vaccine approved for emergency use

Pfizer, BioNTech Vaccine
Pfizer and BioNTech achieve first authorization in the world for a vaccine to combat COVID-19. Courtesy Photo

Kampala, Uganda | URN | The US Food and Drug Administration has authorized the emergency use of Pfizer and BioNTech COVID-19 vaccine in the United States.

The approval of the two vaccines that were produced by US pharmaceutical companies follows data from an independent monitoring board showing that the drug that is given as two shots administered 21 days apart is 95% effective.  

The data, which was also published in the New England Journal of Medicine on Thursday 10, December 2020, comes from more than 43,000 trial participants. 21,720 were randomly given the vaccine and 21,728 were randomly given a placebo.

The data show that there were only eight COVID-19 cases among people who received the vaccine, compared to 162 cases among those given the placebo.

The approving panel of 23 members sat on Friday 11th and according to a statement Saturday 12th morning, found the benefits of the vaccine outweighs its risks.

They note that the vaccine appears to provide some protection of up to 52.4% against COVID-19 following just one dose but warn that the efficacy of one dose can’t be guaranteed since the vaccine trial doesn’t have the single-dose arm.

All participants received a second dose after three weeks. The same design will be used in the emergency rollout of the vaccine on Monday 14th. One-shot will be given to prime the body, and then a few weeks later another shot will be given to boost the response.

Pfizer plans to have 6.4 million doses ready for the US in its first rollout, which is also the world’s most affected country by COVID-19 with more than 290,000 deaths resulting from the respiratory disease. 

The drug has also received regulatory approval in the UK, Canada, Bahrain and Saudi Arabia. In Africa, many countries are awaiting the decision of the COVAX Facility, an initiative of the World Health Organisation [WHO] and GAVI, which is working on equitable access to an effective vaccine by all countries. It is also working on which, of the many vaccines best suits all.

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In countries like Uganda, which have applied to join the COVAX Facility, the vaccine is expected next year and will first be given to health workers. 

Apart from the Pfizer, BioNTech candidate, other vaccines that have recently shown efficacy include those manufactured by Moderna and AstraZeneca.