Pfizer/BioNTech are first coronavirus vaccine makers to seek U.S. authorization

Pfizer/BioNTech are first coronavirus vaccine makers to seek U.S. authorization

The U.S. Food and Drug Administration (FDA) said its vaccines committee would meet on December 10 to discuss the request for emergency use authorization.

"That amount of memory would likely prevent the vast majority of people from getting hospitalized disease, severe disease, for many years", Shane Crotty, one of the leads on the study and a virologist at the La Jolla Institute of Immunology, told The New York Times. Hahn said the agency will publicly post data relating to EUAs for vaccines and other products in an effort to gain the public's confidence and for greater transparency.

The BioNTech/Pfizer shot and another one being developed by United States firm Moderna have taken the lead in the global chase for a vaccine, after large-scale trial data this month showed that their jabs were around 95 percent effective against Covid-19.

The companies "believe in their capability to distribute the vaccine globally upon approval or authorization", they said. "He shares the same passion [as I do] about saving lives and I'm very optimistic that not only will we do very well together bringing a COVID-19 vaccine to the world, but later hopefully a flu vaccine".

The move could mean that millions of doses could be distributed within 24 hours. Interim results from that trial are expected in the coming weeks.

Pfizer and BioNTech have already started rolling reviews of the vaccine with regulators in Europe, Australia, Canada, Japan and the UK. "It's not approved yet", Dr. Marion Gruber, chief of FDA's vaccine office, told the National Academy of Medicine this week. Instead, officials indicated they were considering using expanded access protocols to allow the vaccines to be used.

In my opinion, safety is not compromised by the speed of vaccine development and emergency use authorization.

Moderna said this week it would have 20 million vaccines doses ready to ship in the U.S.by the end of the year, enough to treat 10 million people. That sets the stage for the advisers' daylong debate about any signs of safety concerns and how the new vaccine technology works before rendering a verdict.

COVID-19 patients Possess Resistance for Half a Year, Research finds
The researchers studied all three diseases was to determine why Covid-19 has spread more rapidly than the earlier diseases. He explained after following individuals for six months that the researchers were excited to talk about their outcomes.

20, 2020, Pfizer has asked US regulators to allow emergency use of its COVID-19 vaccine, starting a process that could bring first shots as early as next month.

On Wednesday, Pfizer announced that a final analysis of its vaccine candidate showed that of 40,000 participants who participated in the trial, 170 people had contracted the virus.

But meeting that goal, and providing widespread vaccination by April, will hinge on Pfizer and Moderna avoiding delays that are all too common in the FDA review process.

Earlier this week, the pharmaceutical giant revealed that its experimental vaccine is 95% effective at preventing transmission of the coronavirus, citing a clinical trial involving more than 43,000 people.

Cané said that Pfizer had supply agreements in Chile, Mexico and Peru and that there were several other conversations ongoing, including in Argentina, where the government has said it could receive 750,000 doses of the vaccine by December.

That messenger RNA, or mRNA, instructs the body to make some harmless spike protein, which then trains immune cells to recognize the real coronavirus if it comes along.

Initial doses would be scarce, though, and the Centers for Disease Control and Prevention (CDCP) will decide who is first in line. "This isn't forever", Health and Human Services Secretary Alex Azar said in a briefing Thursday.

Moderna's vaccine also must be kept in a freezer for long-term storage, but at minus 4 degrees Fahrenheit.

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