By Brenda Goodman, CNN
A new type of COVID-19 vaccine will soon arrive at a pharmacy or clinic near you.
The U. S. Food and Drug Administrationhas updated legal vaccines that target the original strain of the coronavirus, as well as the subvariants Omicron BA. 4 and BA. 5. The hope is that those injections will cover against the newly circulating viruses that cause COVID-19.
Who deserves to get those new shots?And why do they deserve one?
Here you will find everything you want to know about bivalent reinforcements.
These new bivalent vaccines involve orders for our cells to protect against two strains of the virus that causes COVID-19. Vaccines direct cells to produce antibodies that bind to parts of the spike proteins of the original strain of the SARS-CoV-2 virus and the subvariants BA. 4 and BA. 5 Omicron, which represent the same tip.
BA. 4 and BA. 5 are the dominant variants in the United States and cause an average of 91,000 new infections each day.
“These are vaccines that are manufactured, manufactured and delivered identically to the COVID mRNA vaccines that most of us have already received,” said Dr. Gregory Poland, who directs the vaccine organization at the Mayo Clinic in Rochester, Minnesota. “In a sense, you just replaced the blueprints. “
However, having twice as many plans doesn’t mean you get twice the dose of active ingredients.
“The overall content of mRNA, the advertising component of the vaccine, that leads to the immune reaction is the same,” said Dr. William Gruber, senior vice president of vaccine studies and progression at Pfizer, which makes one of the most up-to-date vaccines. .
Pfizer’s recall is a 30-microgram dose containing 15 micrograms of mRNA versus the ancestral strain and 15 micrograms versus the BA. 4 and BA. 5 variants. It is allowed from the age of 12.
The company is also renewing its vaccines for children ages 5 to 11 and will apply to the FDA for approval of the updated boosters in early October. Work with the FDA to update vaccines for children ages 6 months to 4 years.
Moderna’s bivalent recall is a dose of 50 micrograms, with 25 micrograms of mRNA designed to combat the ancestral strain of the coronavirus and 25 micrograms of mRNA designed to combat the BA. 4 and BA. 5 variants. It is allowed for other people 18 years and older.
The government has already received orders for those vaccines, and now that the FDA has legalized them, millions of doses will be shipped to tens of thousands of sites across the country. These come with networked gyms, gyms, and pharmacies.
As with previous COVID-19 vaccines, those vaccines will be available for free. But they are possibly among the most recent COVID-19 gifts from the government, which has said it will begin marketing remedies and vaccines this fall.
Pfizer says it has the right to ship up to 15 million doses through Sept. 9.
Meanwhile, a panel of experts advising the U. S. Centers for Disease Control and Prevention is advising the U. S. Centers for Disease Control and Prevention. The U. S. government will read about the science of injections about its vaccine proposals. At an assembly thursday, the Advisory Committee on Immunization Practices will determine who deserves to be vaccinated and when. other people deserve to be vaccinated. If the committee votes to submit them and cdc director Dr. Rochelle Walensky, signature, other people can start getting vaccinated right away.
“What I hope is that after the CDC action, you’ll start to see some sell options that start skyrocketing over the weekend, but very little because of Labor Day weekend. And I hope that next week, or indeed over the next 10 days, you’ll start to see those bivalent vaccines become widely available across the country,” said Dr. Ashish Jha, who leads the White House COVID-19 reaction team. CNN.
Biden’s management expects appointment availability to pile up in the early days, with ample availability in a few weeks. People will look for places in Vaccines. gov.
The government is also preparing to launch a crusade that will inspire Americans to receive an annual flu shot with an updated COVID-19 booster. Research on this technique suggests that it is safe.
Updated COVID-19 vaccines will be the only game in town when it comes to boosters, at least for those over 12. The FDA says older recalls are no longer allowed for this age group, but will still be they can be had as boosters for children ages five to 11.
These are the first COVID-19 vaccines that will be allowed for use in humans after being tested only in mice. It’s pretty much the same procedure you follow every year when annual flu shots are updated.
The FDA has legal bodies to send animal information to speed up those public shootings. Human studies are ongoing, according to Pfizer’s Gruber.
Dr. Peter Marks, who directs the FDA’s Center for Biological Research and Evaluation, said he expects it to be a month or two before human knowledge becomes available.
Officials say the urgency with those withdrawals is warranted in the fall, when COVID-19 is still circulating in the highest degrees and the flu is expected to return.
But the resolution to rely on animal studies has sparked some controversy.
Some vaccine experts say animal studies don’t provide enough evidence for those vaccines at this level of the pandemic.
“You’re asking other people to get a new product for which there’s no data,” Dr. Paul Offit, who runs the vaccine teaching center at Children’s Hospital of Philadelphia, told CNN. “The data in mice are not enough to launch an effort of more than a hundred billion doses. “
Offit says it makes sense to use knowledge from animal studies for annual flu vaccine updates because we’ve been those vaccines for decades and we perceive what biomarkers to look for to assess whether they work. These so-called coverage correlates are not as well understood for COVID-19 vaccines.
It’s not just vaccines that are different, Poland said. At this level of the pandemic, so is our immune system. Almost every single American has become inflamed with the coronavirus, vaccinated, or both. Some other people have gained 4 or five doses of vaccine.
“So if you say, ‘Can you guarantee me that getting dose five or dose six of this new vaccine in the context of having won the previous doses is surely safe?’I would say ‘no, I can’t’. And I think we want to be transparent about it,” Poland said.
FDA officials say animal studies weren’t the only knowledge they analyzed to make their decision. They looked at two other lines of evidence.
The first is about the history of vaccines. The same fundamental vaccines have now been given to billions of people around the world. They have proven to be incredibly effective in preventing serious illness and death from COVID-19. The risks associated with mRNA vaccination are very, very low.
The current line of evidence comes from bivalent vaccines that could soon be used in Europe.
Earlier this year, Pfizer and Moderna presented a panel of independent experts who advised the FDA on knowledge on a bivalent vaccine designed to target the original strain of Omicron, BA. 1. This knowledge showed that vaccines stimulated antibody responses and were well tolerated. Those vaccines are legal, but they won’t be available in the United States.
The BA. 1 strain is no longer circulating and the FDA has asked brands to update their U. S. vaccines to include BA. 4 and BA. 5 instead.
Marks said at a briefing Wednesday that some evidence suggests the BA. 4 and BA. 5 strains generate a more potent immune reaction than BA. 1, which is another explanation for why officials wanted to include them in the updated plans. .
FDA Commissioner Dr. Robert Califf said he understands that other people need to know more, but he’s convinced those vaccines are effective.
“It’s right for other people to ask questions. But it’s actually the most productive consensus we have among experts that this is the most productive way forward. . . It is painful to see other people die needlessly when there is a loose remedy to save you from their death,” he said.
“I’ll be on the front line at the pharmacy to get vaccinated,” said Califf, who turns 71 next month. “I’m very interested in that. “
In the past, testing of variant-specific vaccines has malfunctioned. It’s unclear what effect those bivalent vaccines have.
In a recent pre-printed matrix published before the peer review, the scientists tried to estimate this with a meta-analysis or studies. The estimates collected antibody levels after booster doses against ancestral strains as well as against express variants, and tried to use those grades to be waiting for the efficacy of injections.
They found that other people got the most benefits from getting the booster, period. A withdrawal opposite to the ancestral strain of the virus that explains why COVID-19 has increased neutralizing antibodies 11 times. Scientists estimated that this would increase a person’s coverage. of symptomatic infection over the next six months through 50% to 86. 5%.
The variant-specific reinforcements worked a little better, but the difference wasn’t dramatic. After those injections, coverage against symptomatic infections over the next six months increased to 90. 2%, an increase of 4. 6%.
A recent review of adverse events after mRNA booster shots in adults in the United States found that side effects were less common after booster doses than after momentary doses of the vaccine, and most were mild. About 1 in 8 adults reported headache, fever, or pain after a recall. In children and adolescents, the side effects reported after the recall were injection site pain, fatigue, headache, and muscle pain.
Very rarely, mRNA vaccines can cause myocarditis or inflammation in or around the heart. After more than 80 million booster doses administered in the United States, protective tracking systems obtained 37 verifiable reports of myocarditis. Most of them were men.
The highest rates of myocarditis in adults occurred in younger men, aged 18 to 24 years. For every million booster doses given to men this age, the CDC expects there to be around myocarditis. For teens, the rate is consistent with but still incredibly low: about 11 cases of myocarditis consistent with millions of doses.
Marks said that to minimize that risk, order vaccines to be given at least two months after a previous dose.
“It turns out to be related when they’re around others,” he said.
COVID-19 vaccines will be updated.
As the coronavirus circulated, it replaced a lot. These adjustments helped it outperform the antibodies we made compared to previous versions of the virus and previous versions of the vaccine. As a result, it is more effective in causing reinfections and advanced infections. monoclonal antibodies designed to give passive immunity to the virus to other people have also stopped working in the face of the new variants.
The hope is that giving others up-to-date vaccines will improve their ability to fight infections and coverage for serious illnesses that lead to hospitalization or death.
There is also some hope that the updated boosters will possibly delay the spread of the virus and therefore the speed at which anti-vaccine variants are emerging.
The coronavirus is evolving at lightning speed. At a meeting with FDA vaccine advisers last June, Trevor Bedford, professor of epidemiology and biostatistics at the Fred Hutchinson Cancer Research Center in Seattle, the rate of evolution of the viruses that cause COVID-19 to that of the viruses that cause the flu.
Among the fastest flu viruses, he said, it takes about three years for a new strain to emerge and begin showing up in tests in significant amounts. Among the variants of the virus that causes COVID-19, the Delta variant achieved this feat within a year. Omicron did it in 3 to 4 months.
Therefore, there is a genuine fear that, with nothing to stop the transmission of the infection, we will get stuck in recovery mode, waiting for faster and potentially more harmful variants to emerge.
CNN senior correspondent Elizabeth Cohen contributed to this report.
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