As the FDA OKs new COVID Booster, some questions are needed

Editor’s Note: This story was revised at 4:20 pm

March 29, 2022 – The FDA today allowed Americans over the age of 50 to get a second shot of the COVID -19 booster, even though many infectious disease experts questioned the merits before deciding of the company.

The FDA has granted emergency booster authorization for Pfizer and Moderna to provide a second booster – and a fourth overall shot – for brands over 50 and those over 18 with Defense system.

CDC Director Rochelle Walensky agreed Tuesday to use four boosters, which would allow them to reach American hands.

“The main idea, despite the CDC’s view, is that current drugs are a very good alternative to Omicron and this new type of BA.2 in treating people out of the hospital. hospitalization, and preventing the development of chronic disease, ”William Schaffner, MD, a clinical pathologist at Vanderbilt University in Nashville said before the FDA’s announcement Tuesday.

Of the 217.4 million Americans who were “stuck,” that is, had had two seasons of Pfizer or Moderna’s vaccine or one dose of Johnson & Johnson’s disease, only 45% had a stroke. shot booster, according to the CDC.

“Because it’s not necessary right now for the general public to have a fourth inoculation,” Schaffner said. “Our idea now is to make sure as many people as possible have that [first] booster and fitness. “

Monica Gandhi, MD, an infectious disease specialist at the University of California, San Francisco, admits there is no need for a new stimulant for everyone. The only people who want a fourth shot (or a third, if they have had Johnson & Johnson cancer before) are those over 65 or 70 years old, Gandhi said.

“Older people need those antibodies that are high because they are more susceptible to serious infections,” he said, rather than re -developing.

Eric Topol, MD, executive president of Scripps Research and editor of WebMD Medscape’s sister site, saw the controversy for a fourth disease.

“I would recommend a second effort if you’re more than 4-to-6 months old from your third shot, you’re 50 years old, you’ve endured the first shots well, and you’re nervous. you’re for the BA wave.2 where you’re sitting., or you’re going to have legs as you decide, ”Topol said. “Or if you’re going to or the plans will put you in more trouble.”

To increase or to increase

Daniel Kuritzkes, MD, head of infectious diseases at Brigham & Women’s Hospital in Boston, said it’s a booster time and who needs to rely on what the nation is trying to accomplish with his disease planning.

“Is the goal to prevent any symptomatic disease with COVID-19, is the goal to prevent the spread of COVID-19, or is the goal to prevent serious illnesses that require hospitalization?” Kuritzkes asked.

The current vaccine – including the booster – has prevented serious illness, he said.

An Israeli study showed, for example, that a third dose of Pfizer was 93% better in hospitalization, 92% better in chronic illness, and 81% better in death.

An article published in The Medical Journal of New England He found that Pfizer’s vaccine was 95% effective against COVID-19 infection and did not raise any new safety concerns.

A small piece of Israel, printed on NEJM, A fourth of Pfizer pills given to health care workers were found to prevent symptomatic disease and illness, but significantly less than in previous seasons – about 65%. effect on symptomatic illness, the authors write.

Giving Americans a new boost now – which has been shown to lose effect after 4 months – is what won’t give them protection this fall and winter. , when the disease is on the rise, Kuritzkes said.

And, even if people get stimulants every month, they’re more likely to get a chronic respiratory illness, he said.

“I knew we couldn’t strengthen ourselves without this disease,” Kuritzkes said. “We need to make sure that universal medicine is available to all who do not have access to vaccination.

Motivational combination

The FDA’s April 6 meeting of the Biological Products Advisory Committee and the Biological Products Advisory Committee comes when two major COVID chemical manufacturers – Pfizer and Moderna – have applied for approval. using the emergency valve for a new booster.

Pfizer applied for permission to shoot four to patients over the age of 65, while Moderna wanted the booster to be available to all Americans over 18..

It is unclear what this will mean for the committee’s April 6 meeting. The first guideline said the committee would consider evidence on the safety and efficacy of new vaccines and discuss how to set up a procedure – such as the one used for the disease. influenza virus – which can determine the nature of COVID vaccines when new strains emerge. . He can leave the reason for the annual COVID shooting, if necessary.

The FDA does not make recommendations or decide if – and by whom – Americans will get a COVID booster. That’s the role of the CDC’s Advisory Committee on Immunization Practices.

The last time a booster was considered, CDC Director Rochelle Walensky, MD, dismissed the committee and told all Americans – not just seniors – to get a job. shot COVID again, which became a first motivator.

That past action worries Gandhi, who has called it confusion, and he says may have contributed to the fact that no less than half of Americans chose to get a booster.

Schaffner said he thinks the FDA will allow the use of the problem for the fourth Pfizer and Modern brands, but he doesn’t think the CDC committee will recommend normal use. As we have seen, however, the CDC official should not follow the committee’s advice.

ACIP members “can be more conservative and less conservative in the way they say what needs to be strengthened when mobilization is needed,” Kuritzkes said.

Gandhi said he was concerned that the FDA’s view could be overturned by the influence of Moderna and Pfizer and that “the pharmaceutical industry will be more important than the scientific process.”

There are similar concerns for Schaffner. He said it was “very outrageous” that the producers had used the presses to argue for the stimulants.

“Press releases are not a way to make organic advice,” Schaffner said, adding that “he said. [vaccine makers] sit down and calm down and let the FDA and CDC advisory committee do their thing. “

Paul Burton, MD, the current Chief Medical Officer, told WebMD last week that the symptoms point to why a fourth shot is necessary.

“We’re seeing a decrease in quality, antibody levels are going down, and of course the anti -Omicron effect is going down in 3 to 6 months,” Burton said. “The natural history, from what we see around the world, that BA.2 is here, can change, and I think we will have a new wave of BA.2 in the United States. Gun ʻIa. “

There’s going to be a wave, he said, and “I think we’re going to make less progress. We have to be ready for that, so that’s why we need a quarter.”

Supply problems?

However, the United Kingdom has started giving stimulants to people over 75, and the Swedish health authority has said a fourth shot to people over 80 years old.

That’s what the U.S. – at least on top of its politicians and policy makers – is required to, in effect, continue, say medical experts.

In fact, the Museum keeps four of the photos in the news, saying it has spent all the money to make sure all Americans get one, if any.

On March 23, Jeff Zients, Director of the White House COVID-19, said the federal government’s vaccine for the immunocompromised was enough to get a quarter ”and, if allowed in weeks to in the future, there will be enough supply for a fourth of the costs for our very weakest, including. adults. “

But he said without the council’s approval of a COVID-19 fundraiser, “We can’t get the raw materials needed to support the four shots for all Americans.”

Zients also noted that other countries, such as Japan, Vietnam, and the Philippines, have future incentives and added, “We need to stock up on new supplies now.”

Schaffner said that while it is better to “get a booster on the board,” the U.S. needs to re -intensify the creation of a globally -established process to ensure that the economy is balanced. grains in styles and they are made at the right time.

He and others said he “reminds the public that COVID disease is declining and moving into the aftermath, but that doesn’t mean COVID is over and gone.”

Schaffner said, “We probably want to remember that our defense system is protected.

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