The companies said protection plus a good safety record meant the vaccine should qualify for emergency use authorisation, something the Food and Drug Administration (FDA) can grant before the final testing is fully complete.
Vast wealth and the promise of dramatic change make for cautious optimism concerning Saudi Arabia, the chief executive…58 Views | the publication reaches you by | Saudi Arabia Today
In addition to the FDA submission, they have already started “rolling” applications in Europe and the UK and intend to submit similar information soon.
“While we cannot predict how long the FDA’s review will take, the FDA will review the request as expeditiously as possible,” FDA Commissioner Stephen Hahn said in a statement.
The meeting of the Vaccines and Related Biological Products Advisory Committee will discuss the safety and effectiveness of the vaccine candidate.
The FDA is not obligated to abide by its advisory panel recommendations, but typically does.
Reuters has reported, citing a source, that an FDA panel tentatively plans to meet between December 8 and 10 to discuss the vaccine.
Mr Hahn said the agency had been preparing for the review of emergency use authorisation for COVID-19 vaccines for several months and stood ready to do so as soon as a request was submitted.
With the coronavirus surging around the US and the world, the pressure is on for regulators to make a speedy decision.
“Help is on the way,” Anthony Fauci, the top US infectious disease expert, said on the eve of Pfizer’s announcement, adding that it was too early to abandon masks and other protective measures.
“We need to actually double down on the public health measures as we’re waiting for that help to come.”
How much vaccine is available and when is a moving target, but initial supplies will be scarce and rationed.
Globally, Pfizer has estimated it could have 50 million doses available by year’s end and up to 1.3 billion doses by the end of 2021.
About 25 million may become available for US use in December, 30 million in January and 35 million more in February and March, according to information presented to the National Academy of Medicine this week.
Recipients would need two doses, three weeks apart.
The US Government has a contract to buy millions of Pfizer-BioNTech doses, as well as other candidates that pan out, and has promised shots will be free.
The project for the design, engineering and procurement of the new 400,000m3/day Jubail II seawater reverse osmosis (SWRO)…64 Views | the publication reaches you by | Saudi Arabia Today
Do you have information you want to reach our readers?