Pfizer and BioNTech applied for an emergency permit in the United States for their Covid-19 vaccine on Friday, November 20th.
The FDA will decide if the vaccine is safe to release.
It is unclear how long the FDA will take to study the data. However, the US government expects to approve the vaccine in the first half of December.
Data from an advanced study show that the vaccine protects 94% of adults over 65 years of age.
The Pfizer and BioNTech trial involved 41,000 people worldwide. Half received the vaccine and half a placebo.
If FDA approval comes in the first half of next month, Pfizer and BioNTech will be “ready to distribute the vaccine candidate within hours,” the two companies said.
This would be extremely fast for the development of vaccines – within 10 months after detailing the genetic code. The average wait for approval in the United States is nearly eight years.
On November 19, Pfizer CEO Albert Burla said that filing emergency documents was “a milestone in our journey to deliver the Covid-19 vaccine to the world.”
However, initial doses will be scarce and the Centers for Disease Control and Prevention (CDCP) will decide who is first on the line.
European Commission President Ursula von der Leyen said the EU could also move quickly – by the end of the year.
Pfizer vaccine appears to protect 94% of adults over the age of 65 Modern vaccine shows almost 95% protection against Covid-19 coronavirus: Pfizer vaccine offers 90% protection
Data released this week suggests that the Pfizer and BioNTech vaccine is 95% effective.
This effectiveness is also consistent for age groups – essential given the vulnerability of older people – as well as ethnic groups and gender.
The vaccine also has only mild to moderate and short-term side effects.
It uses an experimental approach called mRNA, which involves injecting part of the genetic code of the virus into the body to train the immune system.
The body then produces antibodies and T cells to fight the coronavirus.
This week, the United States suffered 250,000 deaths from the coronavirus outbreak, the largest in the world.
Its confirmed cases since the beginning of the pandemic amount to 11.7 million, according to research by Johns Hopkins University, again global.
Cases have also risen in the last week, reaching record daily highs.