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What Pfizer’s plan for a third dose of the coronavirus vaccine means to you





CNN

Although the biopharmaceutical company Pfizer has announced that it may be time to consider giving a third dose of its coronavirus vaccine to humans, many doctors and public health officials say it is more beneficial to get shots in the arms of the unvaccinated right now than to boost those who are already fully vaccinated.

“It̵

7;s wonderful to have a booster approved for emergency use on the shelf – ready to use whenever we need it. But I do not think we need it right now, “said Dr. William Schaffner, professor at Vanderbilt University School of Medicine and medical director of the National Foundation for Infectious Diseases, told CNN Friday.

On Thursday, companies Pfizer and BioNTech announced that a third dose of their coronavirus vaccine, given six months after a second dose, appears to maintain “the highest levels of protection” in those vaccinated.

The companies made their announcement without releasing new data, but noted that they would soon need to publish new information. A spokesman for Pfizer later told CNN that the company plans to file an emergency use permit for a booster dose with the U.S. Food and Drug Administration in August.

A few hours after the Pfizer / BioNTech announcement was made, the FDA and US Centers for Disease Control and Prevention pushed back in an unprecedented joint statement stressing that people who are fully vaccinated “do not need a booster shot at this time” and people who are unvaccinated must “be vaccinated as soon as possible to protect themselves and their community.”

The statement also said, “We are prepared for booster doses if and when science shows they are necessary.”

But that science is unclear, and there is still much to learn about the potential need for coronavirus vaccine booster doses. Here’s what we do and do not know.

“We respect what the pharmaceutical company does, but the American public should take their advice from the CDC and the FDA,” said National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci to CNN Friday. “The message is very clear: the CDC and the FDA say that if you have been fully vaccinated by this time, you do not need a booster shot.”

Vaccine manufacturers are looking ahead to what may be needed in the future, while public health officials are focused on the current need for vaccinations, said Dr. Jerome Adams, former U.S. Surgeon General under the Trump administration, CNN’s John Berman Friday morning.

“Companies are considering where the hockey puck is going,” Adams said during a New Day performance. “While the government, the FDA and the CDC, are looking at where the hockey puck is right now. They want to reassure Americans that your best protection is still a vaccine, and you still have good protection – better than the flu shot in a given year – even in the face of variants and declining immunity. ”

Some real evidence of declining immunity with Pfizer’s coronavirus vaccine has emerged in Israel, where the Ministry of Health on Monday issued a brief statement saying an analysis had shown that the coronavirus vaccine was somewhat less protective against serious disease than before and linked this change to the spread of The Delta variant, a more transmissible and possibly more dangerous strain of coronavirus.

The Israeli government statement said that as of June 6, the vaccine provided 64% protection against all infections, including asymptomatic infection and mild illness, and 93% effectiveness in preventing serious illness and hospitalizations.

When it comes to whether booster doses may be needed to help protect humans from new coronavirus variants, Schaffner said the Pfizer vaccine and others have already been shown to still offer some protection.

“It is really unusual for a vaccinated person to be hospitalized today for Covid-related disease, which reinforces the notion that these vaccines still work against the variants,” Schaffner said. The Delta variant now accounts for more than half of all new Covid-19 infections in the United States, according to estimates by the CDC.

Overall, as protection against the severe Covid-19 vaccine is still high, Schaffner said fully vaccinated people should not worry.

“Protection against hospitalization and intensive care unit is hospitalized and death continues – and the antibodies produced by the vaccine really still provide very solid protection for people who have received the vaccine,” Schaffner said, adding that he is fully vaccinated with the Pfizer vaccine.

“We had hoped that the vaccines could not only protect against serious illness, but also our infection. They have a certain impact on reducing our chance of getting infected, ”he added. “It is not as good as we had hoped, but it is less important because the main goal of the vaccine was to keep us out of the hospital, and vaccines continue to do very well.”

Experts say more data is needed to determine if people may eventually need booster doses of Covid-19 vaccines.

An increase in so-called breakthrough cases could potentially provide a clue in the future, federal vaccine advisers said during a June meeting. A “breakthrough” infection refers to Covid-19 cases that occur after someone has been fully vaccinated.

Members of the CDC’s Advisory Committee on Immunization Practice discussed at a meeting last month where it might be time for the agency to make recommendations for vaccine booster doses.

Committee members mostly agreed that more data is needed on the benefits of boosters – but an increase in “breakthrough” infections may be a sign in the future that immunity is declining, and it’s time to to reassess the need for boosters.

“I think the only thing we can do at the moment is if we start to see an increase in re-infections in humans or new infections in humans that have been vaccinated, it’s our suspicion that we have need to move fast, “says ACIP member Dr. Sharon Frey, a vaccine specialist at St Louis University Medical School, said at last month’s meeting.

In general, “what we are looking for is both a very close look at breakthrough cases and also whether there is currently an increase in the elderly – it would be quite clear because they are currently so well controlled,” said ACIP member Dr. Sarah Long, Professor of Pediatrics at Drexel University College of Medicine.

It would be a mistake to give booster doses without both information about number one: Do they boost? And a little bit of safety data, ”Long said. “So we would have an idea that there would be benefit to the booster before we possibly incurred unknown risk.”

In the future, there are some people who may benefit from booster doses of coronavirus vaccine more than others, including those who are immunocompromised. Schaffner said patients who fall into the category represent between 2% and 4% of the U.S. population.

For example, organ transplant recipients may not have an adequate response to coronavirus vaccines because they are taking medication to suppress their immune system. It helps reduce the risk of the body rejecting new organs, but can also limit the reactions to vaccines.

A third dose of coronavirus vaccine could help increase antibody levels among some organ transplant recipients who have not had robust responses to standard vaccination plans, according to a study published in the June Annals of Internal Medicine.

Among patients in the study who had no measurable antibodies after receiving two doses of vaccine, a third of them saw an increase in antibodies after a third dose – and among those with low antibody levels after two doses, all saw an increase after a third dose. .

However, there is not much data on vaccinations in immunocompromised people, because when pharmaceutical companies tested coronavirus vaccines in clinical trials last year, they specifically excluded people who took immunosuppressive drugs because of potential risks.

At last month’s meeting, the CDC’s ACIP panel discussed this and high – risk groups of people – immunocompromised patients, long-term care residents, elderly adults and healthcare professionals – who may benefit from booster doses more than the general public.

“I have personally seen people die well after two full doses of mRNA vaccine because we believe they were immunocompromised and did not have full protection,” said ACIP member Dr. Camille Kotton, who cares for immunocompromised patients at Massachusetts General Hospital and Harvard Medical School.

“So for me, this is the next important limit that we really need and as soon as possible,” Kotton said of booster doses.

Kotton urged his colleagues on the committee to consider continuing with recommendations for booster shots “as soon as we have good science” available on which decisions can be based.

“I would wait for the additional data to be available, including the security data,” Kotton said, adding, “This is a hot topic.”

There are three coronavirus vaccines approved for emergency use in the United States: two-dose Pfizer / BioNTech vaccine for age 12 and older and two-dose Moderna vaccine and one-dose Johnson & Johnson vaccine for age 18 and older.

The companies Pfizer / BioNTech and Moderna have initiated their applications for full FDA approval to use their vaccines, and Johnson & Johnson have said they intend to submit an application but have not yet done so.

To get more people vaccinated against Covid-19, it may be beneficial for the FDA to consider approving Pfizer’s vaccine before approving a booster shot, Dr. Carlos del Rio, executive dean of Emory University School of Medicine, CNN Friday. He added that he received the Pfizer vaccine in December and is not running to find a booster right now.

“The most important thing for the FDA to do right now is not to consider a Pfizer request for a booster shot. It is actually getting full FDA approval for the vaccine because it will change the dynamics, ”said del Rio, adding that it will be easier to get more people vaccinated.

Due to the severity of the pandemic, vaccine manufacturers initially applied for EUAs because the approval process takes less time than would be necessary for full approval. Permission for emergency use is what the name suggests – a medical product, such as a vaccine that receives special FDA approval for use in an emergency.

Advances from authorized to approved would allow manufacturers to market and distribute their vaccines directly. It could also have an impact on vaccine mandates – and perhaps swaying skeptics are hesitant to get the vaccines now.

“I am concerned about the fact that the FDA has honestly not yet given us an update on the full approval of these vaccines, which we know causes hesitation in many people and which also causes companies and companies and schools to delay their decisions. about vaccine mandates, ”Adams said.




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