These people are eligible for a third dose of 1:07 vaccine
(CNN) -
Vaccine makers are bracing for a possible next phase of launching a booster dose of the COVID-19 vaccine.
The US Food and Drug Administration (FDA) on Thursday authorized third doses of the Pfizer / BioNTech or Moderna coronavirus vaccines for certain immunosuppressed people: solid organ transplant recipients or "those who who are diagnosed with conditions that are considered to have an equivalent level of immunosuppression. "
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The Centers for Disease Control and Prevention (CDC) signed the authorization and is now recommending an additional dose of vaccine for certain people.
But these doses are part of the initial vaccination series for people who have not had an adequate immune response.
A booster dose is something different.
Helps renew a declining immune response or helps the body fight an evolving pathogen.
And many Americans who are now ineligible for an additional vaccine wonder when it will be their turn.
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What about booster shots for everyone?
Covid-19 vaccine boosters are not currently needed for the general U.S. population, but the government reviews the data daily and will be ready if this changes, Dr. Vivek Murthy, CEO of the United States, said Thursday. US Health
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"We are trying to understand if there is a decrease in protection that manifests itself as a significant increase in cases of infection in vaccinated, but particularly in hospitalizations and deaths," Murthy told CNN's Erin Burnett.
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Murthy said the government looks at data from drug companies, private healthcare systems and other countries, including those in the UK, Israel and Canada.
"We look at that data regularly, closely. When we see that the threshold is reached, that's when we will recommend boosters for additional people," Murthy said.
"That's a if question. It's a when question, and the data is going to guide our decision on that."
However, the Joe Biden administration is expected to establish a Covid-19 vaccine booster strategy for all Americans vaccinated in September, with possible details on a gradual rollout, starting with the most vulnerable.
The United States can look to vaccination against covid-19 in Israel to get an idea of what might need to be considered in a month or so, Andy Slavitt, the House's former covid-19 response adviser, said Thursday. White.
Israel has authorized booster doses of the COVID-19 vaccine for adults over 50, making it one of the first countries in the world to make such a move.
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"Israel started their vaccination process a little earlier than us, so I think in many respects we've been watching them - and to some extent, the UK - of what we might expect, as well as the people who participated in the original clinical trials of the vaccines in 2020, "Slavitt told CNN's Anderson Cooper on Thursday.
"Those three things together, broadly speaking, give us an idea of what to predict for the future."
Currently, three coronavirus vaccines are licensed for emergency use in the United States: the Pfizer / BioNTech two-dose vaccine for people 12 years of age and older, the Moderna two-dose vaccine, and the Johnson & Johnson single-dose vaccine for all. people over 18 years of age.
Some researchers and health officials suspect that the coronavirus antibodies produced through vaccines may decline over time, possibly after a year or more, and may not protect as well against the variants of the coronavirus that could emerge.
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In July, Israel's Health Ministry said in a statement that it had seen the efficacy of Pfizer's vaccine drop from more than 90% to about 64% as the B.1.617.2 or delta variant spread.
That could mean that a vaccinated person would need a booster dose of the vaccine to stay protected against the original coronavirus variant and emerging variants, including the delta variant, in a manner similar to how a tetanus booster shot is recommended every 10 years or against the flu every year.
In the case of COVID-19 vaccines, it is unknown how long immune protection lasts, but vaccine developers and health officials know that it may not be forever, and that emerging variants could evade immunity.
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This is the opinion of a doctor
"There is a little nuance to covid-19 vaccines," Dr. William Moss, professor and executive director of the International Center for Vaccine Access at the Johns Hopkins Bloomberg School of Public Health, told CNN in May.
While typical booster doses use the same vaccine formula someone received previously to remind the immune system about immunity to a pathogen, Moss said, any future booster against Covid-19 could use altered vaccine formulas.
For example, the companies Pfizer and BioNTech said in a statement that while a third dose of their coronavirus vaccine "has the potential to preserve the highest levels of protective efficacy against all currently tested variants, including delta, the companies remain vigilant and are developing an updated version of the Pfizer-BioNTech COVID-19 vaccine that targets the full-spike protein of the Delta variant. "
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What happens if you miss the booster dose?
Whether or not the doses of the coronavirus booster vaccine are changed, skipping a booster dose, if one is recommended in the future, could leave someone less protected against COVID-19.
"A person who missed a booster is at a higher risk of becoming infected and contracting SARS-Coronavirus-2 disease, but I would also expect them to have some partial immunity and thus may be protected against more serious illness," Moss said in May.
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"They just have a higher risk of infection and disease than someone who received the booster, but they have more immunity than someone who was never vaccinated."
Scientists are also currently investigating whether there is a difference if someone receives the same type of booster vaccine as the original dose given.
Then there is the question of mixing and matching dosages.
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UK researchers reported in May that people who received mixed doses of coronavirus vaccines (who received a different type of vaccine as a second dose than the first) appear to be more likely to experience mild side effects, such as fever, chills, fatigue. or headache.
But the side effects after the vaccine combination were short-lived and there were no other safety concerns, the researchers reported in the Lancet medical journal.
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Who is making the booster shots?
The three companies that have currently licensed the production of coronavirus vaccines in the US (Pfizer, Moderna and Johnson & Johnson) are investigating the potential use of booster vaccines.
"The data that I see coming supports the notion that there will probably be a need for a boost in eight and twelve months," Pfizer CEO Albert Bourla told Axios in May.
"But that remains to be seen and I think that in a month or two we will have enough data to talk about it with much greater scientific certainty."
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The first dose of Pfizer's coronavirus vaccine in the United States was administered on December 14, 2020.
Moderna also runs booster vaccine tests.
The fight against the coronavirus pandemic is expected to continue into next year due to the emergence of variants, Dr. Stephen Hoge, president of Moderna, said during a results call in early May.
"We think this is just the beginning," Hoge said.
"So, as a company, we are committed to making as many updates to the vaccine, adding as many variants as we consider necessary, and making sure that when people receive a [booster] [vaccine, it provides the broadest immune protection against the most. wide range of variants ".
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Johnson & Johnson is also investigating the potential for booster vaccines, the company told CNN in May.
Johnson & Johnson's coronavirus vaccine, along with Pfizer, Moderna and four others, are being tested as seasonal boosters in a study called Cov-Boost being conducted by the UK's National Institute for Health Research and the University of Southampton.
The biotech company Novavax has developed a coronavirus vaccine that CEO Stanley Erck believes could be used as a booster vaccine for people who have already been vaccinated.
The company plans to apply for emergency use authorization for its vaccine in the United States in the fourth quarter of 2021.
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Who has to approve booster vaccines against covid-19?
The decision to widely use booster covid-19 vaccines is expected to involve two agencies, the FDA and the CDC, and the regulatory process for bringing the injections to the arms could vary depending on whether the booster is the same. vaccine that was originally used or is a modified version.
"So if it's the same vaccine, my understanding is that what would have to happen is that the CDC would have to recommend an additional dose with details on when it should occur," Moss said in May.
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In other words, the FDA must authorize the use of the vaccines to be used in new ways, outside of the existing authorization.
The CDC then reports on whether the vaccine should actually be used as authorized by the FDA.
If it's a modified vaccine, "this is where things get interesting and I don't think we know that well," Moss said, but added that the regulatory process could be similar to what happens with flu vaccines each year. .
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"Technically, every time a vaccine like that is modified, it is often considered a new vaccine and you have to go through the whole process again. But there is a precedent, obviously, with vaccines against the influenza virus, not to do that, "Moss said.
"So the flu vaccine every year doesn't have to go through a big phase 3 trial."
This is because the vaccine technology remains the same and the only change is the strain of flu virus that the vaccine is targeting.
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How do you determine that someone needs a booster?
There is no definitive way to know that someone needs an extra dose of the coronavirus vaccine, but so far, studies on booster doses have measured antibody levels.
Cancer patients who receive the COVID-19 vaccine, for example, are less likely to develop protective antibodies, according to two studies published this week in the journal JAMA Oncology.
Antibodies are proteins that the body makes to fight infection.
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However, the researchers noted that the test used to detect COVID-19 antibodies does not provide information on T-cell-based immunity or clinical outcomes related to possible COVID-19 infection.
T cells and B cells are other components of the immune system with immune memory that can protect the body against infection.
In one such study, researchers in Israel followed up on initial findings showing that anti-spike covid-19 antibody levels were significantly lower among cancer patients 5.5 weeks after the second dose of applying. a vaccine with mRNA technology against covid-19, compared to cancer-free patients.
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The team looked at 95 cancer patients and 66 control patients in their initial analysis, which lasted about four months, after their second dose of vaccine. Approximately 87% of cancer patients and 100% of control group patients showed anti-spike antibodies, and antibody levels were still significantly lower in cancer patients. The researchers noted that the mean antibody level for both groups decreased over time.
Separately, among organ transplant recipient patients in a Johns Hopkins University study who had no measurable antibodies after receiving two doses of vaccine, one-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.
Dr. Dorry Segev, study author and founder of the Johns Hopkins University Organ Transplant Epidemiology Research Group, told CNN in June that it is unclear what level of antibodies provides protective immunity.
"We don't know if you need the same extraordinary level of antibodies that people with normal immune systems have," he said.
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How often will a covid-19 booster be needed?
Some experts predict that a booster dose of the coronavirus vaccine might be needed annually, but despite such predictions, Dr. Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases has said that the bottom line is that no one knows yet.
Still, the United States is bracing for the possibility, Fauci said during a White House COVID-19 response team briefing in August.
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Fauci said he believes that eventually everyone will need a booster to maintain full protection against the vaccine.
"We are evaluating this day by day, week by week, month by month, looking at various studies, both international and national," he said.
He added that if immunity appears to decline, or a variant evades the protection offered by current vaccines, health officials will be ready to recommend boosters.
Over time, a booster dose of the COVID-19 vaccine may be just part of the completion of the immunization, not an annual requirement, said Dr. Peter Marks, director of the Center for Evaluation and Health, said last week. FDA Biological Research.
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"I don't think we want to think that these vaccines have failed us in any way," Marks said in a discussion hosted by the Covid-19 Vaccine Education and Equity Project.
"It may just be that to get the really good kind of immunity against COVID-19 that we get with some other vaccines, a series of three vaccines may be necessary, in the same way as adult hepatitis B and the primary vaccination series. multiple child needs to be vaccinated, you know, 0, 1; or 0, 2 and 4; or 0, 2 and 6 months. "
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CNN's Virginia Langmaid, Lauren Mascarenhas, Michael Nedelman and Jen Christensen contributed to this report.
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