Pfizer said Friday it is asking regulators in the U.S. to allow the use of its COVID-19 vaccine emergency, a process the clock began early next month and finally began to limit the first shot as the epidemic ended – not until after one but a long, harsh winter.
Pfizer Inc. And the action comes just days after his German partner, Bioentech, announced his vaccine. Larger, ongoing studies appear to be 95% effective in preventing mild to severe COVID-19 disease.
The companies said that in addition to safety, a good safety record means that vaccine use must qualify for emergency use authorization, which the Food and Drug Administration can provide before final testing is completed. In addition to Friday’s FDA submission, they have already launched a “rolling” application in Europe and the UK and intend to submit similar information soon.
“Our work to deliver a safe and effective vaccine has never been more urgent,” Pfizer CEO Albert Borla said in a statement.
Coronavirus U.S. And as it grows worldwide, regulators are being pressured to make quick decisions.
On the eve of Pfizer’s announcement, Dr. Anthony Fauci, America’s top young infectious disease specialist, said, “Help is moving forward.” He added that it is too early to give up masks and other protective measures. “We really need to redouble public health measures because we are waiting for that help.”
Filing on Friday will close the chain of events as discussed by the FDA and its independent advisers if the shots are ready. If so, yet another government group will have to decide how the initial limited supply should anxiously await the Americans.
How many vaccines are available and when the goal is to run, but initial supplies will be scarce and rationed. Globally, Pfizer estimates it could achieve 50 million doses by the end of the year.
About 25 million may be available for use in the U.S. in December, 30 million in January, and 35 million more in February and March, according to data released this week to the National Academy of Medicine. Recipients will need three doses, except for three weeks.
Rival Moderna Inc. The COVID-19 vaccine is not far behind. Indicates its initial data The shots are as strong as Pfizer’s, and the company also expects to get emergency clearance in a week.
Here’s what happens next:
Disclosure of data
At a public meeting of the FDA’s scientific advisers in early December, the first opportunity for people to see how strong the evidence really is.
So far, what is known is based solely on statements from Pfizer and Biontech. Of the 170 infections found to date, only eight have received the actual vaccine and the rest have received dummy shots. Towards safety, the companies cite the results of 38,000 study participants who were tracked for two months after their second dose. It is a landmark FDA set because historically, the side effects of the vaccine do not go beyond that.
FDA advisor to Children’s Hospital of Philadelphia, Dr. “We will exercise this data,” said Paul Fitte.
Think like science on trial. A few days before the meeting, the FDA will release its own internal analysis. Signs of any safety concerns and sets the stage for a full discussion of consultants on how the new vaccine technology works before presenting a verdict.
They will recommend whether the FDA should only allow the widespread use of the vaccine but if so for whom. For example, is there enough evidence that this vaccine works for older, sick adults and healthier people?
There is no guarantee yet. “We don’t know what that vote will be,” said former FDA vaccine chief Norman Bellor.
Emergency does not use the same as full approval
If there is an emergency green light, the vaccine is still considered an investigator. It’s not valid yet, “Dr. Marianne Gruber, head of the FDA’s vaccine office, told the National Academy of Medicine this week.
This means that anyone who is offered an emergency vaccination must receive a “factsheet” describing the potential benefits and risks before going through the shot.
There will be many strangers. For example, a 95% immunization rate is based on people who developed symptoms and were then tested for the virus. Vaccination can be infected, but there are no symptoms, which is capable of spreading the virus? How long does security last?
That’s why the study needs to be continued – something difficult in terms of ethics, at some stage giving dummy shots to the participants and complicating the search for answers and giving them a real vaccine.
And at least for now, pregnant women will not be eligible because they have not been studied. Pfizer recently began testing the vaccine in children younger than 12 years.
Pfizer’s decision on the vaccine will not affect other COVID-19 vaccine candidates in the pipeline, which will be decided separately.
Manufacturing
The brewing vaccine is more complex than a typical drug product, yet the amount of Pfizer’s Kalamazoo, Michigan, should have the same capacity as the purity and rate before and after the roll out of the factory.
This means that the FDA’s decision is not based solely on study data, but on its determination that the vaccine is being developed properly.
The Pfizer-Bioentech vaccine – and shots of Moderna – are made with new technology. It does not contain the actual coronavirus. Instead, they are made from pieces of the genetic code for the “spike” protein that the virus has studied.
That messenger RNA Or mRNA. Instructs the body to make some harmful spike proteins, training the immune cells to identify if the real virus eventually arrives.
Getting people’s arms
The second government group – consultants from the Centers for Disease Control and Prevention – decides who is number one for rare doses. Health and Human Services Secretary Alex Azar said he hoped the decision could be made in the same way as the FDA.
The pace of the Trump administration’s Operation Operation has worked with states to determine how many doses the vaccinated population needs.
Pfizer will send the supplies as ordered by the states – after the FDA pays.
Baylor has warned that the company’s estimates of how many ships it will ship each month are mere predictions.
“It’s not like pizza,” he said. Manufacturing is so complex that “what you think is not necessary.”
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The Associated Press The Department of Health and Science is supported by the Department of Science Education at Howard Hughes Medical Institute. AP is fully responsible for all content.
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