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Pfizer urges U.S. regulators to approve emergency use of COVID-19 vaccine

Pfizer said Friday it is calling on US regulators to permit emergency use. COVID-19 (new coronavirus infection) (# If there is no character limit, add parentheses when it first appears vaccine. The announcement will bring the first shots limited to next month at the earliest, and will eventually start the watch with a process that could end the pandemic, but not until the end of a long and harsh winter.

The proceedings will be filed days after Pfizer and its German partner BioNTech announced the introduction of the vaccine. 95% valid Preventing mild to severe COVID-19 disease in a large ongoing study.

The two companies said protection and good safety records mean that the vaccine is subject to an emergency license and can be granted by the Food and Drug Administration before the final trial is fully completed. In addition to Friday’s FDA submission, they have already launched “rolling” applications in Europe and the United Kingdom and will soon submit similar information.

“Our efforts to provide safe and effective vaccines are more urgent than ever,” Pfizer CEO Albert Bourla said in a statement.

With the proliferation of coronaviruses in the United States and around the world, regulators need to make swift decisions.

Dr. Anthony Fauci, head of infectious disease experts in the United States, said on the eve of Pfizer’s announcement that “help is on the way,” adding that it is too early to abandon masks and other safeguards. It was. “We really need to double our public health measures because we are waiting for that help.”

The Friday submission will begin a series of events as the FDA and its independent advisors discuss whether shots are ready. If so, yet another government group will have to decide how the first limited supply will be distributed to Americans who are anxiously waiting.

The amount and timing of vaccines available is a mobile target, but the initial supply is in short supply and will be distributed. According to information released this week to the National Academy of Medicine, the Pfizer vaccine could be given about 25 million times in December, 30 million times in January, and another 35 million times in February and March. Recipients will need to take 2 doses every 3 weeks.

Competitors are not too late Moderna Inc.COVID-19 vaccine.. Its early data suggests that Shot is as strong as Pfizer’s, and the company also expects to seek emergency permission within a few weeks.

What will happen next:

Publish data

The first chance to see how strong the evidence really is will take place in early December at a public meeting of the FDA’s scientific advisors.

So far, what is known is based solely on the statements of Pfizer and BioNTech. Of the 170 infections detected so far, only eight were actually vaccinated and the rest received dummy shots. On the safety side, we quote the results of 38,000 study participants who were followed up for 2 months after the second dose. Historically, the side effects of the vaccine have not occurred since then, so this is a milestone set by the FDA.

“We’ll delve into these data,” said Dr. Paul Ofit, FDA adviser to the Philadelphia Children’s Hospital.

Think of it like the science of trial. A few days before the meeting, the FDA will publish its own internal analysis. This sets the stage for all-day discussions of advisors on signs of safety concerns and how new vaccine technologies work before making a verdict.

They would recommend not only whether the FDA should generally allow wider use of the vaccine, but if so, for whom. For example, is there sufficient evidence that the vaccine works for older sick adults as well as for young and healthy people?

There is no guarantee yet. “I don’t know what the vote will be,” said Norman Baylor, a former FDA vaccine chief.

Emergency use is not the same as full approval

In the event of an urgent green light, “the vaccine is still considered under investigation and has not yet been approved,” Dr. Marion Gruber, director of the FDA’s vaccine office, told the National Academy of Medicine this week. ..

That said, anyone who was offered an emergency vaccination would need to get a “fact sheet” to explain the potential benefits and risks before completing the shot.

There are many unknowns. For example, the 95% protection rate is based on people who have been tested for the virus after the onset of symptoms. Can vaccinated people have no symptoms when infected and can spread the virus? How long will the protection last?

Therefore, it is necessary to continue the study of 44,000 people. It’s ethically difficult, but at some point participants who are given a dummy shot will need to be provided with the actual vaccine, complicating the search for answers.

And at least for now, pregnant women are not eligible because they have not been studied. Pfizer has just recently begun testing vaccines in 12-year-old children.

Pfizer’s vaccine decisions do not affect other COVID-19 vaccine candidates in the pipeline and are determined individually.

Manufacturing

Vaccine production is more complex than regular drug production, but the 1 millionth dose from Pfizer’s Kalamazoo plant in Michigan must be of the same purity and potency as all previous and subsequent doses.

This means that the FDA’s decision is based not only on research data, but on the decision that the vaccine is being given correctly.

The Pfizer-BioNTech vaccine (and Moderna shots) is made with a whole new technology. It does not contain the actual coronavirus. Instead, it is made with the genetic code of a virus-studded “spike” protein.

The messenger RNA, or mRNA, directs the body to make harmless spike proteins and trains immune cells to recognize when the actual virus finally arrives.

Enter the human arm

Another government group, an advisor to the US Centers for Disease Control and Prevention, decides who will initially respond to the missing dose. Health and Welfare Secretary Alex Azar said he hopes the decision will be made at the same time as the FDA’s decision.

The Trump administration’s Warpspeed operation worked with the state to align the doses needed to cover the first vaccinated population.

Pfizer will only ship these consumables in accordance with state orders only after the FDA has issued an OK.

Baylor warned that the company’s forecasts for monthly shipments are just forecasts.

“It’s not like pizza,” he said. Manufacturing is so complicated that it “doesn’t always end up in my own way.”

Pfizer urges U.S. regulators to approve emergency use of COVID-19 vaccine

Source link Pfizer urges U.S. regulators to approve emergency use of COVID-19 vaccine

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