Things to know about Pfizer and Moderna's bivalent COVID boosters (2023)

Out of a priority for "transparency and vaccine safety," the US Centers for Disease Control and Prevention and the US Food and Drug Administration said in oneJoint StatementFriday that one of the many vaccine safety monitoring systems detected a potential signal for Pfizer's new COVID-19 booster and stroke risk in adults 65 and older. Older adults are at highest risk for hospitalizations and deaths from COVID-19, which are prevented by booster shots and vaccines.

Though it deserves investigation, the CDC said it's "very unlikely" that there's any real clinical risk, like the many other surveillance systems -- including the Vaccine Adverse Event Reporting System, orVAERS; a preliminary study from the Veterans Affairs Database; and the Pfizer-BioNTech Global Vaccine Safety Database - found no increased risk of ischemic stroke within 21 days of vaccination compared to 22 to 42 days of vaccination.

"All signals require further investigation and confirmation through formal epidemiological studies," health officials said. "When one system detects a signal, the other safety monitoring systems are checked to validate whether the signal represents an actual problem with the vaccine or can be determined as not being clinically relevant." Moderna's bivalent vaccine did not trigger the same preliminary signal , health officials said, and no changes were made to vaccine recommendations for any age group.

In a statement, Pfizer and BioNTech noted that neither the companies, nor the FDA or CDC, have found a potential safety signal outside of the VSD system, and that the companies have in fact observed a "lower number of reported ischemic strokes" to date following a refresh with Pfizer's bivalent vaccine compared to overall incidence rates in the elderly population.

“With hundreds of millions of doses of the original and Omicron BA.4/BA.5-adapted bivalent Pfizer-BioNTech COVID-19 vaccine administered worldwide, the benefit-risk profile of our vaccines remains positive for all approved indications and age groups . ' the companies said.

Health officials have aPublic session on January 26th, which anyone can watch online to discuss COVID-19 vaccines and boosters, and will go through data from the CDC and FDA investigation into the possible but unlikely link between Pfizer's booster and stroke in older adults.

Anyone can have a stroke, but heRisk of doublingfor every decade of life after age 55, according to Johns Hopkins Medicine. Adults over the age of 65 - the only group focused on health officials' investigation announcement - were also at highest risk for severe COVID-19 and have taken this into accountmore than 81% of all deathsfrom COVID-19.

Booster vaccinations were particularly beneficial for the elderly population, preventing serious illness and death. A report released Oct. 7 by the U.S. Department of Health and Human Services found that COVID-19 vaccines were linked to about650,000 fewer hospital admissions and 300,000 fewer deathsamong seniors and others enrolled in Medicare in 2021.

Updated boosters are available in the US for everyone 6 months and older. Here's what we know about them.

What we know about the bivalent vaccines and how well they work

Manufactured by Moderna and Pfizer-BioNTech, the bivalent formulas target both the "original" version of COVID-19 and subvariants BA.4 and BA.5 of omicron. Both are available for adults and children from 6 months.

Although BA.4 and BA.5 are no longer the subvariants that cause disease in the US (XBB.1.5is ready to take overBQ.1 and BQ.1.1),Some laboratory studies suggest sothat the bivalent boosters are sufficient to neutralize XBB.1.5 andprevent serious illnesses. And real-world information supports the effectiveness of the new boosters compared to the original COVID-19 vaccine formulas.

New, real-world data from Israel confirms that the new COVID-19 vaccines formulated to work against the Omicron variant are found to be effective at keeping people out of the hospitalPosted by The Lancet. The study, which has not yet been peer-reviewed, included information from more than 600,000 people aged 65 and over.

This real-world data backs up previous information from the CDC, which found this monthly in November 2022Hospitalization rates for adults who were vaccinated but did not receive an updated booster dose were 2.7 times highercompared to adults who received a new booster dose. The hospitalization rate in unvaccinated adults was 16 times higher than in adults who received a new booster.

Although positive data is now available, a lack of real-world data at the start of the bivalent booster campaign stalled some researchers. When approved by the FDA, the agency made its decision based on clinical trials with a slightly different bivalent booster targeting the BA.1 version of omicron instead of BA.4/BA.5. In addition, there have been studies in mice on the BA.4/BA.5 formula. This approach was previously unprecedented in the COVID-19 vaccine campaign, but health officials say it's not too far removed from the way we approve flu vaccines. Each year the flu vaccine is optimized with a strain believed to be the best target. And the new COVID-19 boosters do not introduce any new vaccine ingredients either.

"Bivalent and multivalent vaccines are widely available, and modifying a vaccine to accommodate different strains of virus often does not require changing other ingredients," said FDA Commissioner Dr. Robert M. Califf in August in atweet. "The FDA has extensive experience reviewing strain changes in vaccines, as is the case with the annual flu shot."

Who can get the Novavax booster?

Adults who have been vaccinated against COVID-19 - but have not yet received a booster - can receive a booster dose of Novavax. It doesn't matter which vaccine you received originally - Pfizer, Moderna, Johnson & Johnson or Novavax.

Read more about the Novavax vaccine here.

When should I get the updated booster?

The updated mRNA boosters (from Pfizer and Moderna) are FDA-approved for adults who have been at least two months since their last dose of vaccine, whether it was a booster or primary series. It doesn't matter what vaccine you originally received, and it shouldn't matter which brand you choose now. Moderna's new booster, like its previous vaccine, is a slightly higher dose (50 micrograms) than Pfizer's (30 micrograms).

It's a little different for babies, toddlers, and preschoolers who are eligible for smaller doses of the updated formulas. Children 6 months to 5 years of age who received Moderna's primary series vaccine will not be able to receive an updated dose of Moderna until at least two months after their second vaccination. Children aged 6 months to 4 years who started Pfizer's primary series can receive the bivalent vaccine as a third dose instead of the "original" third dose. Children in this age group who have already received three doses of Pfizer are not currently eligible for an updated booster dose.

If you are 18 years of age or older and have been vaccinated earlier in the pandemic but have not received a booster dose, you can receive a Novavax vaccine at least six months after completing your primary vaccination course if you prefer it to an mRNA vaccine.

If you are in your 60s or older - or even if you are in your 50s-- the advice among medical experts is clear:Get the updated booster as soon as possible. Older adults are more vulnerable to serious illness and death from COVID-19. If you are younger and have a medical condition that makes you more susceptible to serious illnesses includingdiabetes, heart disease and more, you could also particularly benefit from increasing protection against serious diseases.

Health authorities have encouraged everyone to get their updated boosters, and Moderna and Pfizer-BioNTech have authorized formulas to do sochildren from 5. At an individual level, however, the timing advice for people who have had COVID-19 only recently (we're talking in the last few months, not the last year) is not quite as clear-cut as it is for higher-risk adults or those who have had COVID-19 for several months away from their last bout of COVID-19.

At a panel meeting of the CDC's scientific advisors, a committee that meets before the CDC recommends a vaccine, some members expressed concern that some people would be better off waiting longer than two months between their last shot and this new booster shot , especially people who have recently had COVID-19 and still have relatively high levels of immunity. (In generalVaccine Instructions, the CDC says people can wait three months before getting the shot if they get over COVID-19.)

And while myocarditis is rare overall, younger men and teenage boys doseem to be at higher risk after vaccinationand waiting longer between doses seems to reduce this risk.

From an immune response perspective, some infectious disease doctors havesuggested waiting four to six monthsbetween your last COVID-19 infection or vaccination to get the most out of the new booster shot. faucisaid PBSthat if you have recently tested positive for COVID-19 you should "wait approximately three months, at least three months from the time you had a previous infection" before receiving the new booster. Fauci added that because he had COVID-19 in mid and late June, he waited until late September for the refresher.

Fauci got his booster live on The Late Show With Stephen Colbert in early October.

But individual immunity is only one piece of the puzzle when we're talking about a respiratory virus as contagious as COVID-19. People who may have only very mild symptoms that they dismiss as colds or allergies can still pass an infection on to their more susceptible family or friends.

"Even if you're on the low-risk side yourself, you'll have family and friends who will see you," said Dr. Ashish Jha, the coordinator of the White House COVID-19 response team, on Andy Slavitt's podcast in October, asreported by CNBC.

"You don't want to be the person your grandma gives it to be."

Dr. Jayne Morgan, executive director of the COVID task force at Piedmont Healthcare, said it's important to get a booster now so we can "steer" the tide of the pandemic.

"They want this booster while Omicron is in circulation. The whole point of releasing the booster now is so we can stop chasing this variant," Morgan said, adding that it's unclear what variants or sub-variants will be in our future if (or how much) they will differ Deprive our protection from vaccines, infections and treatments.

The vaccinations and booster vaccinations have proven effectiveparticularly effectiveto prevent serious illnesses in older adults. A report released Oct. 7 by the U.S. Department of Health and Human Services found that COVID-19 vaccines were linked to about650,000 fewer hospital admissions and 300,000 fewer deathsamong seniors and others enrolled in Medicare in 2021. More than81% of COVID-19 deathsoccur in people over the age of 65, according to the CDC.

Where can I get the new booster?

You should be able to use the vaccine search pageVaccines.govto find an updated vaccine in your area. When selecting your upgraded booster from either Pfizer-BioNTech or Moderna, make sure you select the shot that says: "Newly approved bivalent" in bold. Vaccines of the first series or the first two doses are still available for people who have not yet received a vaccine.

Smaller doses of the original vaccines are still available for children from 6 months. For those getting the Novavax booster, you can find it at "primary vaccines."

Can I get a flu shot at the same time as my booster shot?

Yes, according to the CDC. There areno recommended waiting timebetween seasonal influenza vaccination and COVID-19 vaccines.

Until now,the current flu seasonis the worst since the 2010-2011 flu season.

The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified healthcare provider with any questions about a medical condition or health goals.