Pfizer says it is seeking emergency use of COVID-19 vaccine Friday

Joanna Estrada
November 21, 2020

USA drugmaker Pfizer Inc PFE.N is hoping to rapidly roll out its experimental COVID-19 vaccine around Latin America soon after it gets emergency authorization in the United States, a senior executive said, which could be as early as next month.

The companies expect the FDA to grant the EUA by mid-December and said they will begin shipping doses nearly immediately.

If approved, the Pfizer vaccine would require two separate doses given about three weeks apart. Unlike conventional vaccines that are produced using a weakened form of the virus mRNA vaccines use the pathogen's genetic code.

The more people who can experience milder symptoms and recover at home, the less burden on the health care system and the less exposure that health care workers will have to the virus, which all contributes to better control of the pandemic.

Moderna Inc is expected to be the next company to seek a U.S. emergency use nod for a Covid-19 vaccine. Still, FDA guidelines sought to set a high standard for a vaccine, even under emergency authorization. Despite repeated claims, we are still months away from the coronavirus vaccine, therefore, limited options are left for us to remain honest to our duties toward society and its people to save the nation from this deadly virus. And scientists at the University of Oxford, working with AstraZeneca, reported that their experimental vaccine could protect older people from getting severely ill from the new coronavirus.

The FDA will review data on the safety and effectiveness of the vaccine and also consult an outside panel of vaccine experts, a process that could take weeks.

Mr Hancock said the companies had already begun submitting data to the MHRA and would submit their full data in the coming days.

If there's an emergency green light, "that vaccine is still deemed investigational".

He added: "However, each national regulatory agency may still come to different conclusions - which is normal - because each must make their own benefit risk assessment".

There will be a lot of unknowns.

Then come those over 65, and younger people who are at-risk. Pfizer's vaccine can be stored in conventional freezers for up to five days, or in the special coolers for up to 15 days, as long as the dry ice is replenished and the boxes are not opened more than twice a day.

It's when regulators allow shots to be given to certain people while studies of safety and effectiveness are ongoing.

And at least for now, pregnant women won't qualify because they weren't studied. Pfizer only recently began testing the vaccine in children as young as 12.

Experts say this is not a rubber stamping process and regulators will apply the same stringent criteria to Covid vaccines as they would to others.

A medic in a protective suit and mask holds an injection syringe and vaccine.

He said the speed of the roll-out of a vaccine would depend on the speed it could be manufactured. "And if supported by the data, the FDA is likely to issue an EUA for this vaccine".

The Pfizer-BioNTech vaccine and Moderna's shots are made with brand-new technology. They are made using messenger RNA, or mRNA, which works by giving cells a recipe to produce a protein located on the exterior of the SARS-2 virus, the spike protein.

Pfizer's shares were up 1.3% and BioNTech shares up 9.3% in NY late on Friday afternoon, as the possibility of a vaccine soon raised hopes for the end of a pandemic that has claimed more than a quarter of a million lives in the United States and over 1.3 million worldwide.

"Pfizer's partner BioNTech has announced that tomorrow they intend to file for emergency use authorization at the FDA", health secretary Alex Azar told a press conference Thursday in Washington.

Company projections of how much it will ship each month are just predictions, Baylor warned. Manufacturing is so complex that "you don't necessarily end up with what you thought".

Other reports by Click Lancashire

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