Early data indicates Pfizer/BioNTech's COVID-19 vaccine is 90% effective

25 Novembre, 2020, 23:06 | Auteur: Auguste Feret
  • Wilmington PennsylvaniaNov. 7 2020 President-elect Joe Biden addresses supporters at Chase Center in Wilmington DE on Nov 7 2020 after being named the winners

A potential COVID-19 vaccine being developed by American pharma giant Pfizer and Germany-headquartered BioNTech is 90% effective, early data from a phase III trial suggests.

In an announcement released today, Pfizer and BioNTech said that their vaccine achieved an efficacy rate of over 90% seven days after receiving the second dose. Once the government agency has received and analysed two months' worth of trial safety data on at least half of the study's participants, the vaccine developers can apply for the authorisation. Data showed that COVID-19 protection occurred 28 days after the initial vaccine through a two-dose inoculation schedule.

Pfizer and BioNTech are now looking to file an emergency use authorisation with the US Food and Drug Administration (FDA). The FDA states that a coronavirus vaccine must have an effectiveness rate of at least 50pc.

If authorized for emergency-use, the number of doses will initially be limited.

The companies added that they are accumulating safety data and now estimate that a median of two months of safety data following the second dose of the vaccine will be ready by the third week of November.

They notably have agreements with the USA to provide up to 500 million doses.

Does this mean the vaccine will receive emergency approval in the US?

The Phase III trials of Pfizer's vaccine have enrolled 43,538 participants since July 27.

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The firm has said 42% of global trial sites and 30% of USA trial sites involve volunteers of racially/ethnically diverse backgrounds.

The clinical trial will now continue until there have been 164 confirmed Covid-19 cases in vaccinated and placebo groups, in order to collect further data and characterise the vaccine candidate's performance. More safety and additional efficacy data will be collected over the remainder of the Phase 3 trial.

"With today's news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis".

William Schaffner-an infectious diseases expert at Vanderbilt University School of Medicine-told Reuters, "The efficacy data are really impressive". Schaffner said the data looks promising, even though the study isn't complete.

Pfizer and BioNTech expect to have a median of two months of safety data, following the second dose of BNT162b2, available by the third week of November.

"The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine's ability to prevent COVID-19", Dr Albert Bourla, Pfizer Chairman and CEO, was quoted as saying in the release.

India's indigenous COVAXIN-developed by Bharat Biotech-is expected to be ready by February 2021.



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