WASHINGTON (AP) — The U.S. approved updated COVID-19 vaccines Monday, hoping to rev up protection against the latest coronavirus strains and blunt any surge this fall and winter.

The Food and Drug Administration decision opens the newest shots from Moderna and Pfizer and its partner BioNTech to most Americans even if they’ve never had a coronavirus vaccination. It’s part of a shift to treat fall updates of the COVID-19 vaccine much like getting a yearly flu shot.

There’s still another step: The Centers for Disease Control and Prevention must sign off. A CDC advisory panel is set to issue recommendations Tuesday on who most needs the updated shots. Vaccinations could begin later this week, and both the COVID-19 and flu shot can be given at the same visit.

A third vaccine maker, Novavax, said its updated shot is still being reviewed by the FDA.

COVID-19 hospitalizations have been rising since late summer although –- thanks to lasting immunity from prior vaccinations and infections –- not nearly as much as this time last year.

But protection wanes over time and the coronavirus continually churns out new variants that can dodge prior immunity. It’s been a year since the last time the vaccines were tweaked, and only about 20% of adults ever received that earlier update.

“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” FDA vaccine chief Dr. Peter Marks said in a statement. “We very much encourage those who are eligible to consider getting vaccinated.”

Just like earlier vaccinations, the fall round is cleared for adults and children as young as age 6 months. FDA said starting at age 5, most people can get a single dose even if they’ve never had a prior COVID-19 shot. Younger children might need additional doses depending on their history of COVID-19 infections and vaccinations.

The FDA pointedly isn’t calling this latest round a “booster” but instead a vaccine updated to better match the currently circulating virus. The new recipe targets an omicron variant named XBB.1.5 — replacing outdated combination vaccines that mixed protection against the original coronavirus strain and an older version of omicron.

And while even the XBB.1.5 variant is no longer dominant, FDA determined that it’s close enough to coronavirus strains causing most COVID-19 illnesses today to offer good cross-protection. Like earlier versions, they’re expected to be most protective against COVID-19’s worst consequences rather than mild infection.

But while the FDA’s decision allows for wide use of the updated shots, the CDC will decide how strongly different groups are urged to get them.

Federal officials have said the shots still will be free to most Americans through private insurance or Medicare. But for the uninsured or underinsured, the CDC is working with health departments, clinics and certain pharmacies to temporarily provide free shots.

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Nearly 20 million lives were saved by COVID-19 vaccines during their first year, but even more deaths could have been prevented if international targets for the shots had been reached, researchers reported Thursday.

On Dec. 8, 2020, a retired shop clerk in England received the first shot in what would become a global vaccination campaign. Over the next 12 months, more than 4.3 billion people around the world lined up for the vaccines.

The effort, though marred by persisting inequities, prevented deaths on an unimaginable scale, said Oliver Watson of Imperial College London, who led the new modeling study.

“Catastrophic would be the first word that comes to mind,” Watson said of the outcome if vaccines hadn’t been available to fight the coronavirus. The findings “quantify just how much worse the pandemic could have been if we did not have these vaccines.”

The researchers used data from 185 countries to estimate that vaccines prevented 4.2 million COVID-19 deaths in India, 1.9 million in the United States, 1 million in Brazil, 631,000 in France and 507,000 in the United Kingdom.

An additional 600,000 deaths would have been prevented if the World Health Organization target of 40% vaccination coverage by the end of 2021 had been met, according to the study published Thursday in the journal Lancet Infectious Diseases.

The main finding — 19.8 million COVID-19 deaths were prevented — is based on estimates of how many more deaths than usual occurred during the time period. Using only reported COVID-19 deaths, the same model yielded 14.4 million deaths averted by vaccines.

The London scientists excluded China because of uncertainty around the pandemic’s effect on deaths there and its huge population.

The study has other limitations. The researchers did not include how the virus might have mutated differently in the absence of vaccines. And they did not factor in how lockdowns or mask wearing might have changed if vaccines weren’t available.

Another modeling group used a different approach to estimate that 16.3 million COVID-19 deaths were averted by vaccines. That work, by the Institute for Health Metrics and Evaluation in Seattle, has not been published.

In the real world, people wear masks more often when cases are surging, said the institute’s Ali Mokdad, and 2021′s delta wave without vaccines would have prompted a major policy response.

“We may disagree on the number as scientists, but we all agree that COVID vaccines saved lots of lives,” Mokdad said.

The findings underscore both the achievements and the shortcomings of the vaccination campaign, said Adam Finn of Bristol Medical School in England, who like Mokdad was not involved in the study.

“Although we did pretty well this time — we saved millions and millions of lives — we could have done better and we should do better in the future,” Finn said.

Funding came from several groups including the WHO; the UK Medical Research Council; Gavi, the Vaccine Alliance; and the Bill and Melinda Gates Foundation.

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Parents who thought their children under 5 would have to wait several more months for COVID-19 vaccinations instead just might get them as early as March. Here’s what needs to happen first, and some things to expect if they do become available in the U.S.

GOVERNMENT REVIEW

Pfizer has asked the Food and Drug Administration to authorize extra-low doses of its COVID-19 vaccine for children ages 6 months through 4 years. The FDA will review the application and convene a panel of outside advisers in mid-February to debate the data. The FDA will use that advice in deciding whether the new doses are safe and effective enough for the youngest children.

But that’s not the last step. The Centers for Disease Control and Prevention will gather its own expert panel to help decide if the shots should be recommended for this age group — and if so, for all of them or only those at higher risk from COVID-19.

SPECIAL SHOTS

Shots for children in this age group are one-tenth the size of the adult doses. That’s even smaller than the doses given for 5- to 11-year-olds, which are one-third the dose. Pfizer will have to specially bottle the extra-low doses so vaccine providers don’t mix them up with the two other dosages already being used.

TWO DOSES OR THREE?

Here’s where this gets complicated. In December, Pfizer announced a setback: Preliminary study results showed two of the extra-low doses appeared strong enough to protect babies but weren’t strong enough for 2- to 4-year-olds. The company added a third shot to the study, but results are not expected until late March.

Still, the FDA took the highly unusual step of urging Pfizer to apply now for a two-dose series with potentially a third shot added later. During the FDA advisory committee meeting, the public will get its first look at any new evidence of whether two extra-low doses are working better than initially expected among the preschoolers.

IF CLEARED, WHERE WOULD SHOTS BE GIVEN?

While the government expanded pharmacists’ ability to vaccinate children during the pandemic, shots for the youngest children primarily are given in pediatricians’ offices.

WHAT ABOUT KIDS YOUNGER THAN 6 MONTHS?

There are no plans to test shots in newborns.

WILL THE SHOTS BE IN HIGH DEMAND?

Vaccinations have been lower among children than in other age groups, a pattern likely to continue with kids under 5. As of last week, just 20% of kids ages 5 to 11 and just over half of 12- to 17-year-olds were fully vaccinated, according to the American Academy of Pediatrics. Nearly three-quarters of adults are fully vaccinated. While COVID-19 tends to be less severe in children than adults, the omicron wave has caused record numbers of child hospitalizations.

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Here are a few of the lies Californians are being told in an effort that surely has helped sicken many:

Take a COVID-19 vaccination and your life span will be shortened. Get the shot and you will be sterilized or become impotent. Shots include the insertion of tracking bots. The pandemic is a government-created conspiracy.

These are absolute falsehoods, pure shibboleths, but in the parts of California with the lowest average levels of educational attainment, they and other falsehoods are in large part responsible for holding down vaccination rates and keeping caseloads high.

They have made COVID-19 — in the age of some of history’s most effective vaccines — mostly a disease of the gullible and the fearful.

Two neighboring counties show how this plays out:

As of mid-December, Riverside County, with 2.47 million population, had seen 5,402 COVID -related deaths over the last two years, while Orange County, with 3.5 million persons, had 5,746 deaths. That’s about 225 deaths per 100,000 population in Riverside County to only about 164 deaths per 100,000 population in a next-door county.

No one can be absolutely sure, but some information suggests that folks in Orange County might be better trained to see through lies than those in Riverside County. U.S. Census figures show 40.6% of Orange County’s adult populace with college degrees compared with about 22% in Riverside County.

This may be a key reason only 55.6% of eligible Riverside County residents were fully vaccinated (two doses), compared with 63.9% in Orange County.

For sure, vaccinations are saving lives in both counties. It is primarily the unvaccinated who are dying today from this now-preventable virus.

The difference is even more striking in Kern County, with lower educational attainment rates than either Riverside or Orange counties, and a fully vaccinated rate of only about 44%. So far, about one in every six Kern County residents has contracted COVID within the last two years.

All this raises a vital question: Since educational attainment takes many years to achieve, how can less educated Californians best be inoculated against the anti-vaccination propaganda spewed daily, almost hourly, on social media sites like Facebook, Twitter and TikTok?

One way could be via government censorship of those sites. But that runs counter to the First Amendment, which gives anyone the right to prevaricate, even when their lies prove fatal for others.

Best would be to launch a torrid, carefully-timed campaign of pro-vaccination information. One tactic might be to place public service ads on virtually every TV show and social media outlet, juxtaposing their messages with the anti-inoculation lies and vivid illustrations of their consequences.

California government is already set up to do this kind of thing, its anti-tobacco campaign many years old and with proven results including a far lower smoking rate among teenagers than 20 years ago.

Those ads often feature videos of lung cancer, asthma and emphysema victims coughing and wheezing while they bemoan their onetime smoking habits.

Why not imitate this, making videos in COVID intensive care units around the state, with terminal victims on ventilators relieved of their breathing tubes just long enough to say how much they regret believing the anti-vax propaganda.

Another might be thorough newspaper and television analysis of anti-vaccination articles posted frequently by organizations like the national Children’s Health Defense group, headed by Robert F. Kennedy Jr., who uses his name and pedigree to peddle misleading information about COVID vaccines, just as he has through many years of lying about immunizations for other diseases like rubella, mumps, measles and polio.

It would help to show graphically how anti-vaxxers often lift numbers from reports of the Centers for Disease Control and use them out of context. Newspaper ads or TV commercials could show how apparently adverse statistics may at first appear large, but are actually minuscule, extremely tiny compared to the total number of vaccinations given.

So far, there is no steady campaign to debunk the lies and half-truths purveyed by anti-vaxxers. Meanwhile, the numbers from various California counties demonstrate how dangerous and damaging those untruths are, even today, when the combination of vaccines and masks make COVID pretty much an optional disease, mostly victimizing the gullible.

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WASHINGTON (AP) — Members of the U.S. military will be required to get the COVID-19 vaccine beginning next month under a plan laid out by the Pentagon Monday and endorsed by President Joe Biden. In memos distributed to all troops, top Pentagon leaders said the vaccine is a necessary step to maintain military readiness.

Defense Secretary Lloyd Austin said the mid-September deadline could be accelerated if the vaccine receives final FDA approval or infection rates continue to rise.

“I will seek the president’s approval to make the vaccines mandatory no later than mid-September, or immediately upon” licensure by the Food and Drug Administration “whichever comes first,” Austin said in his memo, warning them to prepare for the requirement.

The Pentagon plan provides time for the FDA to give final approval to the Pfizer vaccine, which is expected early next month. Without that formal approval, Austin needs a waiver from Biden to make the shots mandatory, and Biden has already made clear he supports it.

Austin’s decision reflects similar moves by governments and companies around the world, as nations struggle with the highly contagious delta variant that has sent new U.S. cases, hospitalizations and deaths surging to heights not seen since last winter. The concerns are especially acute in the military, where service members live and work closely together in barracks and on ships, increasing the risks of rapid spreading. Any large virus outbreak in the military could affect America’s ability to defend itself in any security crisis.

Austin warned that if infection rates rise and potentially affect military readiness, “I will not hesitate to act sooner or recommend a different course to the President if l feel the need to do so. To defend this Nation, we need a healthy and ready force.”

In a statement Monday, Biden said he strongly supports Austin’s message to the force and the plan to add the COVID vaccine “to the list of required vaccinations for our service members not later than mid-September.”

Biden said the country is still on a wartime footing and “being vaccinated will enable our service members to stay healthy, to better protect their families, and to ensure that our force is ready to operate anywhere in the world.”

Austin’s memo, which went out Monday, was followed quickly by one from Army Gen. Mark Milley, chairman of the Joint Chiefs of Staff.

“The Secretary of Defense intends to mandate vaccinations for all Service members in the coming weeks,” said Milley, adding that the military’s medical professionals recommended the move. At the bottom of his message, Milley scrawled a handwritten note: “Getting vaccinated against COVID-19 is a key force protection and readiness issue.”

The decision comes a bit more than a week after Biden told defense officials to develop a plan requiring troops to get shots as part of a broader campaign to increase vaccinations in the federal workforce.

More broadly, the COVID-19 crisis has worsened around the country, with hospitals experiencing deeper strain in unvaccinated areas of the South. Mississippi reported that 35 medical centers are completely out of intensive care unit beds, Arkansas topped its pandemic record for COVID admissions, and the average number of people hospitalized nationwide has returned to levels not seen since February. More patients are being parked in emergency rooms while they wait for beds to open up and the average number of daily deaths is now above 500.

The country is averaging about 108,000 new infections and 700,000 vaccines administered a day.

Austin said the military services will have the next few weeks to prepare, determine how many vaccines they need, and how this mandate will be implemented. The additional time, however, also is a nod to the bitter political divide over the vaccine and the knowledge that making it mandatory will likely trigger opposition from vaccine opponents across state and federal governments, Congress and the American population.

Pentagon spokesman John Kirby said Monday that he believes the military has enough vaccines to meet the requirements. He added, “You can consider this memo not just a warning order to the services but to the troops themselves.”

Democratic and Republican leaders of the House Armed Services Committee said vaccines have proven effective.

“Some may try and criticize the Secretary’s decision, using anti-vax arguments that are not supported by facts or science to politicize the conversation. These desperate attention seekers must be ignored,” said Rep. Adam Smith, D-Wash., chairman of the House Armed Services Committee. Rep. Mike Rogers, R-Ala., said the vaccine will help protect troops who live in cramped conditions and don’t have the option to telework.

The decision will add the COVID-19 vaccine to a list of other inoculations that service members are already required to get. Depending on their location, service members can get as many as 17 different vaccines.

Austin’s memo also said that in the meantime, the Pentagon will comply with Biden’s order for additional restrictions on unvaccinated federal personnel, including masks, social distancing and travel limits.

According to the Pentagon, more than 1 million troops are fully vaccinated and another 237,000 have received one shot. But the military services vary widely in their vaccination rates.

The Navy said that more than 74% of all active duty and reserve sailors have been vaccinated with at least one shot. The Air Force, meanwhile, said that more than 65% of its active duty and 60% reserve forces are at least partially vaccinated, and the number for the Army — by far the largest service — appears to be closer to 50%.

Military officials have said the pace of vaccines has been growing across the force, with some units — such as sailors deploying on a warship — seeing nearly 100% of their members get shots. But the totals drop off dramatically, including among the National Guard and Reserve, who are much more difficult to track.

Some unvaccinated troops have said they’d get the shot once it’s required, but others are flatly opposed. Once the vaccine is mandated, a refusal could constitute failure to obey an order and may be punishable under the Uniform Code of Military Justice.

Army guidance, for example, includes counseling soldiers to ensure they understand the purpose of the vaccine and the threat the disease poses. The Army also notes that if a soldier “fails to comply with a lawful order to receive a mandatory vaccine, and does not have an approved exemption, a commander may take appropriate disciplinary action.”

Military service officials have said they don’t collect data on the number of troops who have refused other mandated vaccines, such as anthrax, hepatitis, chicken pox or flu shots over the past decade or more. And they weren’t able to provide details on the punishments any service members received as a result of the refusal.

Officials said they believe few troops have refused other mandated vaccines, and the discipline can vary.

Also, service members can seek an exemption from any vaccine — either temporary or permanent — for a variety of reasons including health issues or religious beliefs. Regulations involving the other mandatory vaccines say, for example, that anyone who had a severe adverse reaction to the vaccine can be exempt, and those who are pregnant or have other conditions can postpone a shot.

According to defense officials, senior military leaders support making the shot mandatory. In some cases, commanders have struggled to separate vaccinated recruits from unvaccinated recruits during early portions of basic training in order to prevent infections. So, for some, a mandate could make training and housing less complicated.

Navy officials said last week that there has been only one case of COVID-19 hospitalization among fully vaccinated sailors and Marines. But, the Navy said there have been more than 123 hospitalizations in a similar group of unvaccinated sailors and Marines.” It said fewer than 3% of its immunized troops have tested positive for COVID-19.

The other military services did not provide similar data.

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Dozens of Americans are rolling up their sleeves for a third dose of COVID-19 vaccine — this time, shots tweaked to guard against a worrisome mutated version of the virus.

Make no mistake: The vaccines currently being rolled out across the U.S. offer strong protection. But new studies of experimental updates to the Moderna and Pfizer vaccines mark a critical first step toward an alternative if the virus eventually outsmarts today’s shots.

“We need to be ahead of the virus,” said Dr. Nadine Rouphael of Emory University, who is helping to lead a study of Moderna’s tweaked candidate. “We know what it’s like when we’re behind.”

It’s not clear if or when protection would wane enough to require an update but, “realistically we want to turn COVID into a sniffle,” she added.

Viruses constantly evolve, and the world is in a race to vaccinate millions and tamp down the coronavirus before even more mutants emerge. More than 119 million Americans have had at least one vaccine dose, and 22% of the population is fully vaccinated, according to the Centers for Disease Control and Prevention. Much of the rest of the world is far behind that pace.

Already an easier-to-spread version found in Britain just months ago has become the most common variant now circulating in the United States, one that’s fortunately vaccine-preventable.

But globally, there’s concern that first-generation vaccines may offer less protection against a different variant that first emerged in South Africa. All the major vaccine makers are tweaking their recipes in case an update against that so-called B.1.351 virus is needed. Now experimental doses from Moderna and Pfizer are being put to the test.

In suburban Atlanta, Emory asked people who received Moderna’s original vaccine a year ago in a first-stage study to also help test the updated shot. Volunteer Cole Smith said returning wasn’t a tough decision.

“The earlier one, it was a great success and, you know, millions of people are getting vaccinated now,” Smith told The Associated Press. “If we’re helping people with the old one, why not volunteer and help people with the new one?”

The study, funded by the National Institutes of Health, isn’t just testing Moderna’s experimental variant vaccine as a third-shot immune booster. Researchers at Emory and three other medical centers also are enrolling volunteers who haven’t yet received any kind of COVID-19 vaccination.

They want to know: Could people be vaccinated just with two doses of the variant vaccine and not the original? Or one dose of each kind? Or even get the original and the variant dose combined into the same injection?

Separately, the Food and Drug Administration has given Pfizer and its German partner BioNTech permission to start similar testing of their own tweaked vaccine. The companies called it part of a proactive strategy to enable rapid deployment of updated vaccines if they’re ever needed.

The Moderna and Pfizer vaccines, like the majority of COVID-19 vaccines being used around the world, train the body to recognize the spike protein that is the outer coating of the coronavirus. Those spikes are how the virus latches onto human cells.

Mutations occur whenever any virus makes copies of itself. Usually those mistakes make no difference. But if a lot of changes pile up in the spike protein — or those changes are in especially key locations — the mutant might escape an immune system primed to watch for an intruder that looks a bit different.

The good news: It’s fairly easy to update the Moderna and Pfizer vaccines. They’re made with a piece of genetic code called messenger RNA that tells the body how to make some harmless spike copies that in turn train immune cells. The companies simply swapped out the original vaccine’s genetic code with mRNA for the mutated spike protein — this time, the one from South Africa.

Studies getting underway this month include a few hundred people, very different than the massive testing needed to prove the original shots work. Scientists must make sure the mRNA substitution doesn’t trigger different side effects.

On the protection side, they’re closely measuring if the updated vaccine prompts the immune system to produce antibodies — which fend off infection — as robustly as the original shots do. Importantly, lab tests also can show if those antibodies recognize not just the variant from South Africa but other, more common virus versions, too.

Some good news: Antibodies aren’t the only defense. NIH researchers recently looked at another arm of the immune system, T cells that fight back after infection sets in. Lab tests showed T cells in the blood of people who recovered from COVID-19 long before worrisome variants appeared nonetheless recognized mutations from the South African version. Vaccines trigger T cell production, too, and may be key to preventing the worst outcomes.

Still, no vaccine is 100% effective — even without the mutation threat, occasionally the fully vaccinated will get COVID-19. So how would authorities know an update is needed? A red flag would be a jump in hospitalizations — not just positive tests — among vaccinated people who harbor a new mutant.

“That’s when you’ve crossed the line. That’s when you’re talking about a second-generation vaccine,” said Dr. Paul Offit of Children’s Hospital of Philadelphia, a vaccine adviser to the Food and Drug Administration. “We haven’t crossed that line yet, but we might.”

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