A committee of experts from the U.S. Food and Drug Administration (FDA) decided on Friday to recommend approval of a booster dose of Pfizer's coronavirus vaccine only for people 65 and older. and those with serious immune problems, leaving out the bulk of the vaccinated population over 16 years of age.
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Prior to the committee's decision, we spoke with two experts to better understand what is known so far about the COVID-19 vaccine boosters, if they are effective and necessary, and who could benefit the most from them.
This is what they told us:
Why are booster shots necessary?
"We may need backup if there is evidence that people no longer have immunity, especially against severe COVID-19," explains epidemiologist Sandra Albrecht, a professor at Columbia University in New York.
"Boosters are given when the initial response to a series of vaccines diminishes over time, but data is still being collected to understand the immune response to COVID vaccines over time," adds Dr. Jenell Stewart, Specialist in infectious diseases and professor at the International Center for Clinical Research at the University of Washington.
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Stewart notes that it hasn't been long since the first thousands of people started getting vaccinated against COVID-19, "so you will hear a wide variety of opinions on how to interpret the data that is available," he says.
What is clear is that people with weakened immune systems, such as transplant recipients, need a third dose to get the same strong immune response from COVID mRNA vaccines that most people get. after two doses.
"That is why it is recommended that this group receive a booster now,"
explains Dr. Albrecht.
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In fact, in mid-August the FDA authorized boosters for people with severe immune problems, including those who have received organ transplants and are taking immunosuppressive drugs and those undergoing cancer treatment.
Several studies in people over 60 years indicate that the effectiveness of vaccines decreases after a few months.
A study conducted with residents of nursing homes in New York found that the effectiveness of messenger RNA vaccines (Pfizer and Moderna) dropped from 92% to 53% between May and the end of July.
But the data collected seems to be insufficient for experts to be clear about how unprotected people are vaccinated over time.
"We don't yet know if this decline means that people are less able to fight COVID-19," explains Dr. Albrecht.
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These kinds of doubts weighed on the FDA committee's decision not to give the go-ahead for blanket approval of a vaccine booster.
"The incremental benefits for the younger population have not been fully demonstrated. I believe that at this time we must specifically target the people most likely to be at high risk and that is the older population, the immunocompromised, obese, people with diabetes ... "said Dr. Michael Kurilla, an official with the National Institutes of Health and one of the committee members who voted against the recommendation.
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Data from other vaccines, such as influenza, show that people over 65 years of age do not develop such a robust immune response to vaccines and, therefore, immunity decreases more rapidly over time, the doctor explained to Noticias Telemundo Jenell stewart
"It is for this reason that we administer high-dose flu vaccines to our older patients. If someone in the general public can soon benefit from a third dose, it is more likely to be those over 65," he said.
Who might be the first people to get a booster dose and when?
The goal of the Centers for Disease Control and Prevention (CDC) is to begin applying boosters in early fall, but that is subject to FDA approval.
It is not clear how the decision of the Advisory Committee on Vaccines and Related Biologicals not to recommend its general application will affect that process.
According to the CDC, people will be eligible after 8 months of receiving the second dose of the mRNA vaccines (either Pfizer-BioNTech or Moderna).
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However, enforcement of the boosters for those who qualify would follow a priority list.
They will start with the same people who got the vaccine first - that is,
those who are most at risk of becoming seriously ill: immunosuppressed people, primary health care and medical personnel, nursing home residents, and other older adults.
The FDA committee's decision culminated several weeks of debate among the scientific and medical community on whether to give booster injections to already vaccinated people or whether the focus should instead be on getting unvaccinated people to be immunized. both in the United States and in the poorest and most lagging countries in the immunization process.
In the United States, the information on whether a boost is needed has been mixed, to say the least.
In mid-August the Biden Administration announced that a third dose of the vaccine would be necessary and that it would begin to be administered on September 20 to all people over 12 years old, still without knowing if the FDA would approve it.
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But health authorities warned the White House that that would not be possible and asked it to postpone the plan to offer reinforcements to the general public this month.
Not only is the information available from Pfizer insufficient for the authorities to make a decision, as evidenced in Friday's vote, but regulators need more time to define the appropriate dose of a possible third injection of Moderna because the authorization request sent by the company also suffered from insufficient data.
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On September 9,
President Biden acknowledged the mess the White House caused and left the decision to health authorities.
"I know there has been some confusion about the reinforcements," he said.
The committee's decision, not to recommend the approval of a booster for people under 65, comes as a serious blow that will surely bring down Biden's plan to strengthen immunization of the general public.
The FDA is not required to follow the recommendations of its advisory committee, but it usually does.
Do COVID-19 Vaccine Boosters Work?
Some preliminary studies have preliminarily shown that
a third dose does increase the protection of vaccinated people against the virus.
A study conducted in Israel and published Sept. 15 in the New England Journal of Medicine found that people over the age of 60 who received a booster dose had an 11 times lower risk of getting the virus than people who did not receive the booster. booster, 12 days after receiving the injection.
Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases has said that data from Israel supports the theory that a third dose is beneficial in increasing protection against COVID-19 and said that, in his opinion, it could well be that this is not considered as a booster but as part of the initial vaccination regimen, as is done with vaccination against other diseases.
A man receives the third dose of Pfizer's COVID-19 vaccine in Ramat Gan, Israel, on August 30, 2021. In Israel, people over 60 years of age who have been vaccinated with Pfizer for at least five months received a booster.
Oded Balilty / AP
"From my own experience as an immunologist, it would not surprise me at all if the complete and appropriate vaccination regimen is probably three doses," said Fauci, who explained that this decision will have to be made by the FDA after analyzing the data from the studies.
"Because this third dose is part of the initial immune response, you will hear that many people avoid calling it a boost," says Dr. Jenell Stewart.
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Pharmaceutical Pfizer insists that a third dose of its vaccine is needed to boost protection between six and 12 months after full vaccination with the current two doses and presented data showing that an additional injection given six months after the second injection increases antibody levels five to 10 times against the virus that causes COVID-19.
But these data did not convince the committee of experts that the reinforcements are necessary at this time.
So healthy people with no major risk factors don't need a booster shot?
"At the moment the reinforcements are not necessary, especially for healthy people," answers specialist Sandra Albrecht.
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For Dr. Stewart, the criterion of success that was demonstrated during clinical trials of vaccines remains valid: preventing serious infections that require hospitalization.
"Despite concerns about delta-variant infections among immunized people,
those who are vaccinated remain protected from hospitalization for severe COVID infections," he
explains.
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This criterion is consistent with a report published last week in the scientific journal The Lancet, in which a group of scientists, including two FDA officials, concluded that booster vaccines are not necessary at this time for the general public.
The scientists noted that although effectiveness may decline over time, the protection it provides against serious disease persists.
Is a booster the same as the vaccines we already received?
Yes, it is the same type of vaccine, with the same ingredients and dosage of the initial doses.
Although studies are underway to evaluate the potential benefits or harms of using a different type of booster vaccine, Dr. Stewart explains.
Both Dr. Stewart and epidemiologist Albrecht believe that the current discussion should be focused on how to get unvaccinated people to receive the injection - as of today in the United States only 6 out of 10 people over the age of 12 are fully vaccinated and the Latinos lag further behind - and increase vaccine use in poorer countries.
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“Personally, I am very concerned about the ethics of offering booster vaccines to the general public, when so many people around the world have not yet had access to their first dose of the COVID vaccine.
By definition, this pandemic is a global problem and must be addressed as such, ”says Stewart.
“In my opinion, the focus should be on vaccinating people who have not yet received any doses.
Hospitals are filling up across the country with people who are not vaccinated, ”says Albrecht.
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In the past seven days, the United States has recorded an average number of 11,000 daily hospitalizations for COVID-19, although the number has decreased about 6% since the first week of September.
However, the number of deaths continues to rise: as of September 15, an average of 1,900 daily deaths were recorded according to a database from The New York Times.
So far, the COVID-19 pandemic has infected more than 40 million people in the United States and claimed nearly 700,000 lives nationwide, or one death for every 500 Americans.