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Aug. 31, 2022 – The FDA on Wednesday granted emergency use authorization to Omicron-specific COVID-19 vaccines made by Pfizer/BioNTech and Moderna.

The agency cited data to support the safety and efficacy of this next generation of mRNA vaccines targeted toward variants of concern.

If you’ve been waiting to get a variant-specific booster shot, you may be in luck as early as next week.

The Pfizer EUA corresponds to the company’s combination booster shot that includes the original COVID-19 vaccine as well as a vaccine designed to protect against the most recent Omicron variants, BA.4 and BA.5.

The Moderna combination vaccine will contain both the firm’s original COVID-19 vaccine and a vaccine to protect specifically against Omicron BA.4 and BA.5 subvariants.

As of Aug. 27, BA.4 and BA.4.6 accounted for about 11% of circulating variants, and BA.5 made up almost all the remaining 89%, CDC data show.

The next step will be a review of the scientific data by the CDC’s Advisory Committee on Immunization Practices, which is set to meet Thursday and Friday. The final hurdle before distribution of the new vaccines will be a sign-off on CDC recommendations for use by agency Director Rochelle Walensky, MD.

“If you’ve not yet received a booster dose or it’s been several months since your last booster dose, now is the time to consider getting one,” Peter Marks, MD, director, FDA Center for Biologics Evaluation and Research, said during a virtual FDA news conference. 

“Also, if you’ve not yet vaccinated your children, now is a great time to consider taking them along to receive their vaccination as well,” he said.

“Unfortunately, COVID-19 continues to cause devastating consequences throughout the country with nearly 400 deaths and over 5,000 new hospitalizations every day,” FDA Commissioner Robert M. Califf, MD, said. “And just yesterday provisional CDC data indicated that US life expectancy fell again in 2021, In large part due to COVID deaths.”

“Regrettably only about half of eligible Americans have received their first booster,” he continued. “So, this is a remarkable opportunity to improve our life expectancy.”

CDC data indicate that those who are up to date on their vaccines are 13 times less likely to die from COVID compared to those who have not received the vaccine and are 3 times less likely to die from COVID compared to those who only had one booster instead of two.

“It’s just painful to see people dying unnecessarily when there’s a free treatment that would prevent their death,” said Califf, noting that protection against death associated with the COVID-19 vaccines “is much more clear than anything I’ve ever seen.”

Protection Now and In the Future

Scientific modeling suggests “that we are looking at a possible fall wave with a peak around Dec. 1,” Marks said. “By giving the booster now, we will hopefully both control the current plateau that we’re in — we’re dropping off very slowly — as well as address this future potential wave that looms out there.”

Califf noted that the new vaccines have another potential long-term benefit, protection against long COVID, “which for young people is increasingly a major concern.”

“I want to make clear that these updated boosters present us with an opportunity to get ahead of the next wave of COVID-19,” Califf said. “And for those who may be wondering, CDC says you may get a COVID-19 booster at the same time as your annual flu shot.”

The FDA will continue to study how well the new vaccines protect again COVID going forward, Marks said.

And another hope is that these next generation vaccines will provide stronger protection, Marks said.

“The idea here is not just to increase the antibodies right now, but also to hopefully give us a longer duration of protection,” he said.

If this holds true, then Americans might need fewer booster shots in the future.

“Hopefully [this] holds us for as much of the entire season.”

Aug. 31, 2022 – COVID-19 booster vaccines targeting the Omicron BA.4 and BA.5 subvariants currently dominating in the United States could be available in the next few days, but their arrival comes with some controversy.

The FDA granted emergency approval to the mRNA boosters from Pfizer and Moderna today. Next up are meetings of the CDC’s Advisory Committee on Immunization Practices on Thursday and Friday that could pave the way for an official CDC endorsement of the vaccines before the weekend.

The U.S. government has already purchased over 170 million doses of the two vaccines to be ready for use after all approvals are in place (with an order of 4 million more doses for children, should those be approved later).

But the expected arrival of the updated vaccines has sparked debate among infectious disease experts and others.

Some have criticized the fact that the new boosters haven’t been tested in humans and say they will wait to get the updated booster or skip it altogether. Others worry that the public will view the new vaccines as rushed, increasing an already reluctant public’s hesitation to get another shot.

Still, many experts applaud the speed with which the updated vaccines were developed and say the safety of the COVID-19 vaccines is well-established. They say this transition to updating vaccines for COVID-19 is being done much like the U.S. updates its flu vaccine annually, tweaking the formula of an established vaccine platform to combat new viruses or variants expected to be circulating.

The Route to the New Boosters

Earlier this year, vaccine makers gave the FDA data on an updated vaccine that targeted BA.1, the Omicron variant that was dominant earlier. But then, the FDA asked the companies to update their vaccines to add an Omicron BA.4/5 component, to create a vaccine that is a bivalent booster – meaning it will cover both the original strain of the virus that emerged from China and the newer  BA.4 and BA.5 subvariants.

This will be the first update to the mRNA vaccines since they became available in December 2020.

The FDA’s Vaccines and Related Biological Products Advisory Committee met with vaccine makers in late June to review data on Omicron-specific COVID-19 vaccine candidates.

For the new boosters, the FDA did not schedule another meeting of its vaccine advisory panel, according to FDA Commissioner Robert Califf, MD. He noted on Twitter that “the agency feels confident in the extensive discussion that was held in June.”

Evidence on Updated Boosters

At the end of June, Pfizer BioNTech and Modernapresented the FDA with human data on the BA.1 vaccine. The companies also presented lab or animal data on the BA.4 and BA.5 vaccine candidates.

Both companies showed that the BA.1 vaccines triggered antibody responses to BA.4 and BA.5, but lower than those for BA.1. 

The companies also presented data that showed the updated shots’ side effects were similar to those of the original vaccine, such as soreness where the shot was given and fatigue.

In mice studies presented to the FDA, Pfizer said its new booster increased the antibody responses to all the Omicron variants, including BA.4 and BA.5.

Results from human clinical trials are coming, but not soon. Moderna just completed enrollment of its BA.4 and BA.5 booster clinical trial, with results expected in the fourth quarter of 2022. Pfizer said it plans to start a trial soon.

Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, told NPR that the data from the mouse studies suggests the new vaccines may be about 20 times more protective against Omicron than the original shots.

In response to any concerns about safety data in humans from the new vaccine, CDC Director Rochelle Walensky, MD, recently told CNBC that the new shots involve very small changes in the mRNA sequence and that should not impact safety.

Infectious Disease Experts Weigh In

The lack of convincing neutralizing antibody data against BA.4 and BA.5 in people is a problem, says Paul Offit, MD, an infectious disease expert and director of the Vaccine Education Center at Children’s Hospital of Philadelphia. 

“At the very least, what I’d like to see is neutralizing antibody data in people who have gotten this BA.4 , BA.5 vaccine as compared to just getting the monovalent vaccine and to see a dramatic increase in neutralizing antibodies, a 4- or 5-fold increase,” he says.

Offit also questions which groups should get the updated vaccine based on benefit and believes the best approach is to target those most at risk of severe COVID-19, such as older adults, people with serious medical conditions, or those with weakened immune systems.

“Those are the ones getting hospitalized,” he says. He sees the goal of the updated vaccine as preventing serious illness.

Offit, who says he has been vaccinated and boosted, and had a mild COVID-19 infection about 3 months ago, plans to skip this booster.

Eric Topol, MD, executive vice president of Scripps Research and editor-in-chief of Medscape (WebMD’s sister site for medical professionals), applauded the FDA’s “aggressive and expedient” approach, with a BA.5 vaccine available for review just 2 months after the FDA meeting asking for such a vaccine.

He pointed out that mice data is used every year to update the flu vaccine quadrivalent program. “But there’s a concern that it’s not so easy to extrapolate mouse to human for SARS-CoV-2, a virus that’s quite different than influenza,” he wrote online in his online platform Ground Truths.

Another potential concern, Topol and others say, is something called imprinting, also known by the catchy but potentially misleading term “original antigenic sin,” with a person’s first exposure to a virus having an effect on a later response to similar viruses. The worry is people may “train” their immune system to remember the response to the first infection and be less able to respond to future ones when faced with different variants, such as those targeted by the new boosters.

For now, he says, “it’s an unknown, the data are mixed.”

Will the Public Accept It?

Topol has also expressed concern about public trust in the vaccine and the chance that people will view the new boosters as a rush job. As he also pointed out, just 32% of the population has had any of the original booster shots.

Topol’s personal decision? He is about 8 months out from his fourth shot and said he will wait to see more data. He said that is simply his perspective. “Many will be eager to get the new shot. As I said, that’s fine.”

Infectious disease expert William Schaffner, MD, a professor of preventive medicine at Vanderbilt University in Nashville, isn’t as concerned as others about the lack of human data, citing the need to fight the expected winter surge.

“If you need a vaccine to combat what some think will be an increase in [cases in] the winter, you won’t have an updated vaccine in time if you wait for a clinical trial,” he says.

He, too, likens the tweaking of the COVID-19 vaccine to what’s done annually with the flu vaccine.

As for safety, “we know a vast amount about the [vaccine’s] safety and effectiveness,” Schaffner says. “I think the majority of the public health and vaccinology communities are quite content that we are doing these immune-bridging studies that show [updated vaccines] performed similarly to previous vaccines.”

As for safety concerns, he says the risk of myocarditis (inflammation of the heart muscle), which occurred in some teens and young adults with the second dose of the vaccine, was lower with the booster dose. He says it’s reasonable to expect the updated booster to also carry a lower risk of that side effect.

“These tweaks [with the updated vaccine] are so small, it won’t impact safety,” said Katelyn Jetelina, PhD, an epidemiologist and health policy expert who publishes Your Local Epidemiologist,  a newsletter translating science for consumers.

She recognizes the concern about imprinting, but “we need to be responsive to the needs of our immune system right now, in the midst of [an expected] surge,” she said.

Jetelina acknowledges the unknowns, such as how long the updated vaccine could be effective. Because BA.5 is so new, there hasn’t been time to analyze the vaccine in people. In her view, “demanding an effective vaccine and clinical data is simply a fantasy against this rapidly changing virus.”

As for experts who want to focus just on those at risk of severe disease, she says any advance that helps cut the risk of infection is important: “We cannot stop severe disease and death if we don’t stop transmission. Even if we don’t stop transmission perfectly, even if it’s 50%, that still helps a lot.”

She plans to get the updated booster.

By Laurie McGinley, The Washington Post

Aug. 31, 2022 — New coronavirus boosters are just around the corner following authorization Wednesday by federal regulators. The updated shots are designed to provide a stronger shield against the BA.4 and BA.5 omicron subvariants still causing tens of thousands of infections and hundreds of deaths every day in the United States.

The boosters will be part of a campaign by the federal government, to be kicked off within days, to persuade Americans to bolster their immune defenses before a potential surge in covid-19 cases as cooler weather arrives in the fall.

But the updated boosters have generated some controversy and confusion. Here’s what you need to know.

When will the shots be available?

The boosters, after receiving emergency use authorization from the Food and Drug Administration, now have to get the blessing of the Centers for Disease Control and Prevention and its advisers. That review is scheduled for Thursday. If all goes as expected, some shots could be available this weekend, with more available right after Labor Day.

Where can I get one and how much will it cost?

The new boosters, which are intended as single shots, will be available at the same places where the previous boosters and vaccines have been available – at doctors offices, hospitals, pharmacies and community health clinics.

Like the other coronavirus shots, the updated boosters have been purchased by the federal government and will be free to consumers.

Who are the boosters for?

The CDC is expected to recommend the shots for the same ages authorized by the FDA: 12 and older for the new booster from Pfizer and its German partner, BioNTech, and 18 and up for the Moderna booster. Officials are expected to consider use of the updated booster in younger children later. Anyone who has received the two-shot primary series of the mRNA vaccines and the single-shot Johnson & Johnson vaccine will be eligible, regardless of whether they received any – or all – of the recommended booster shots.

The existing vaccine will continue to be used, but only for the initial two-shot series of the mRNA, not as a booster.

If I just got a booster of the original vaccine, should I get the new one right away?

No. The FDA said people who recently received their initial vaccine or a booster should wait two months before getting the updated booster. Getting the new booster too soon could limit its effectiveness.

What are the side effects of the boosters?

Side effects are not expected to differ from those associated with the current vaccine, which include redness and swelling at the vaccine site, as well as occasional fatigue, headache and muscle soreness, according to the CDC. More serious reactions are rare.

The Washington Post’s Lena H. Sun contributed to this report.

Aug. 31, 2022 – People who lift weights understand they’re playing a long game.

Once they get past the “newbie gains” – the quick and exciting increases in muscle strength and size – it takes time, effort, and patience to keep making progress.

Whether they know it or not, they’re also playing the longevity game.

A growing body of research shows that resistance training adds years to both lifespan and “healthspan” – the period of life when we’re in good health.

A 2022 study review from Japanese researchers linked “muscle-strengthening activities” to a 15% lower risk of dying.

Resistance exercise was also linked to a lower risk of cardiovascular disease (17%), cancer (12%), and diabetes (17%).

We’ve known for a long time that strength is an excellent predictor of future health. Lots of research has shown that, if all else is equal, stronger men and women have a much lower risk of dying during a given period than people with less strength.

This new research shows that strength training offers similar protection, regardless of the results of that training. So even if you don’t think you’re getting as strong or as lean as you’d like to be, you should keep it up – because chances are, you’re still helping your health in a big way.

How Strength Training Helps as You Age

For longevity, strength training seems to be especially effective for older adults, says Tufts University professor Roger Fielding, PhD, who’s been studying the role of exercise in the aging process since the early 1990s.

“With aging, we see clear deficits in muscle function and bone health,” he says. “That all can be slowed, attenuated, or reversed with appropriate exercise.”

His concept of “appropriate” has changed a lot in the past 3 decades. “When I first started studying this stuff, we would try to give people a very formalized prescription” for strength training, he says.

That strength training prescription typically included a lot of sets (three per exercise), moderate reps (eight to 12 per set), and relatively heavy weights. It also required professional supervision in a well-equipped gym, which was both unappealing and impractical for most of the target population.

“What I’ve learned is that even lower-intensity strength training, at home, without a lot of specialized equipment, has some benefits,” he says.

Which benefits? That’s harder to say.

The research linking resistance exercise to lower mortality comes from large, population-wide surveys, looking at tens or even hundreds of thousands of people. The broad category of “muscle-strengthening exercises” can include anything from calisthenics in the living room to a serious bodybuilding or powerlifting program.

They’re also based on self-reporting by the people studied. Because of that, “we should be careful how we interpret some of these studies,” Fielding says.

How Much Strength Training Should You Do?

That warning seems especially appropriate for the study’s most surprising conclusion: The maximum longevity benefit comes from one or two resistance exercise sessions a week totaling 30 to 60 minutes.

The study adds that it’s unclear why more strength training would have diminishing or even negative returns.

Robert Linkul, owner of Training the Older Adult in Shingle Springs, CA, thinks the answer is perfectly clear.

“Less might be more for the beginning lifter,” he says. That’s why his new clients typically begin with two 50-minute workouts a week. But after 3 months, they need to train three times a week to continue seeing gains.

He currently has 14 clients who have been with him at least 16 years. Most of them started in their 50s and are now in their 60s or 70s. If there were any downside to working out more than two times a week, he’s pretty sure he would’ve seen it by now.

Live Longer and Move Longer, Too

Linkul says that his training program includes a lot more than lifting. Clients start each workout with 10 to 15 minutes of mobility and warmup exercises. That’s followed by 15 minutes of strength training and 15 minutes of high-intensity resistance training (HIRT).

HIRT uses functional exercises – lifting and carrying dumbbells or kettlebells; pushing or pulling a weighted sled – to improve strength and endurance at the same time.

“Most of the clients I get are training for real-life function,” Linkul says.

Falling is one of their biggest concerns, and for good reason: According to the World Health Organization, it’s the second-leading cause of unintentional injury-related deaths worldwide, behind only traffic accidents.

Their other major concern is losing their independence, which often follows a fall. “They want to feel they’re not near using a cane or a walker or being stuck in a wheelchair,” he says. “The more we train, the further we get from that.”

That’s where strength training offers its most unique advantages, according to a 2019 study from researchers at McMaster University. Resistance exercise is “particularly potent for maintaining mobility in older adults,” the study says.

Training for Life

Traditional aerobic exercise also offers many of the same benefits, including longer life and a lower risk of cardiovascular disease, cancer, and diabetes.

But there’s no need to choose one or the other. As a recent study noted, combining aerobic and strength exercises leads to a lower risk of early death than either of them separately.

Which makes perfect sense to Fielding.

“Usually, people who’re physically active aren’t just doing strength training alone,” he says. “Some exercise is better than no exercise,” and more is usually better than less. “People have to find things they like to do and want to do and are able to do consistently.”