Day: April 19, 2023

Older Americans and people with weak immune systems can get an extra COVID-19 booster dose this spring.

The Centers for Disease Control and Prevention on Wednesday signed off on a more flexible booster schedule for people who remain at the highest risk from COVID-19 — giving them the choice of a second “bivalent” Pfizer or Moderna booster, the most up-to-date formula.

“Many in the population are experiencing vaccine fatigue but there is a subset who are eager to receive additional doses,” CDC’s Dr. Sara Oliver told an agency advisory panel that expressed support for the change.

The move came a day after the Food and Drug Administration took steps to make coronavirus vaccinations simpler for everyone. From now on, anyone getting a Pfizer or Moderna dose — whether it’s a booster or their first-ever vaccination — will get an updated version rather than the outdated original shots.

Here are some things to know:

Who needs a booster?

Anyone who’s gotten their original vaccinations but hasn’t had an updated booster yet can still get one. Only 42% of Americans 65 and older — and just 20% of all adults — have gotten one of those updated boosters since September.

Who can get a second updated booster?

People 65 or older who already had one Pfizer or Moderna updated booster can roll up their sleeves again, as long as it’s been at least four months since that last shot.

The schedule is a little different for people with weak immune systems. Most can choose a second Pfizer or Moderna updated booster at least two months after their first. Under the latest FDA and CDC guidelines, they also could get additional doses if and when their physician decides they need one.

Why the extra leeway?

Older adults continue to have the highest rates of hospitalization from COVID-19, even as cases have declined. But a frail 85-year-old may want another booster right away, while a robust 65-year-old may not see the need — or might instead time another shot for peak protection ahead of a summer vacation or other special event.

CDC officials stressed there’s even more variety among immune-compromised patients, from people with only mild impairment to those trying to replenish immunity that grueling cancer treatment knocked out.

The changes put the U.S. in line with Britain and Canada, which also are offering certain vulnerable populations a spring shot. It’s a reasonable choice, Dr. Matthew Laurens, of the University of Maryland School of Medicine, said before the announcement.

“We do have vaccines that are available to protect against these severe consequences, so why not use them?” he said. “They don’t do any good just sitting on a shelf.”

Will younger, healthier people get a fall dose?

Stay tuned. The FDA will hold a public meeting in June to consider if the vaccine recipe needs more adjusting to better match the latest coronavirus strains — just like it adjusts flu vaccines every year. And part of that discussion will be whether younger, healthier people also need a booster.

The updated Pfizer and Moderna shots being used now target the BA.4 and BA.5 omicron versions, which have been replaced by an ever-changing list of omicron descendants. Still, while protection against mild infections is short-lived, those updated doses continue to do a good job fighting severe disease and death even against the newest variants.

Tots are least likely to be vaccinated yet

CDC’s advisers were dismayed at how few of the youngest children are vaccinated. Just 6% of 2- to 4-year-olds have gotten their initial COVID-19 shots and 4.5% of those younger than 2. Far fewer got an updated booster.

The FDA’s new rules mean tots under 5 who’ve never been vaccinated can get the most up-to-date formula — two Moderna shots or three of the Pfizer-BioNTech version. Unvaccinated 5-year-olds can get two Moderna doses or a single Pfizer shot. And tots already fully or partially vaccinated may get a bivalent shot or two depending on their vaccination history.

What about the Novavax vaccine?

Novavax makes a more traditional type of COVID-19 vaccine, and its original formula remains available for people who don’t want the Pfizer or Moderna option. Novavax also is getting ready in case FDA urges a fall update, by manufacturing several additional formulas.
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The Supreme Court is deciding whether women will face restrictions in getting a drug used in the most common method of abortion in the United States, while a lawsuit continues.

The justices are expected to issue an order on Wednesday in a fast-moving case from Texas in which abortion opponents are seeking to roll back Food and Drug Administration approval of the drug, mifepristone.

The drug first won FDA approval in 2000, and conditions on its use have been loosened in recent years, including making it available by mail in states that allow access.

The Biden administration and New York-based Danco Laboratories, the maker of the drug, want the nation’s highest court to reject limits on mifepristone’s use imposed by lower courts, at least as long as the legal case makes it way through the courts. They say women who want the drug and providers who dispense it will face chaos if limits on the drug take effect. Depending on what the justices decide, that could include requiring women to take a higher dosage of the drug than the FDA says is necessary.

Alliance Defending Freedom, representing anti-abortion doctors and medical groups in a challenge to the drug, is defending the rulings in calling on the Supreme Court to let the restrictions take effect now.

The legal fight over abortion comes less than a year after conservative justices reversed Roe v. Wade and allowed more than a dozen states to effectively ban abortion outright.

Even as the abortion landscape changed dramatically in several states, abortion opponents set their sights on medication abortions, which make up more than half of all abortions in the United States.

The abortion opponents filed suit in November in Amarillo, Texas. The legal challenge quickly reached the Supreme Court after a federal judge issued a ruling on April 7 that would revoke FDA approval of mifepristone, one of two drugs used in medication abortions.

Less than a week later, a federal appeals court modified the ruling so that mifepristone would remain available while the case continues, but with limits. The appeals court said that the drug can’t be mailed or dispensed as a generic and that patients who seek it need to make three in-person visits with a doctor, among other things.

The generic version of mifepristone makes up two-thirds of the supply in the United States, its manufacturer, Las Vegas-based GenBioPro Inc., wrote in a court filing that underscored the perils of allowing the restrictions to be put into effect.

The court also said the drug should only be approved through seven weeks of pregnancy for now, even though the FDA since 2016 has endorsed its use through 10 weeks of pregnancy.

Complicating the situation, a federal judge in Washington has ordered the FDA to preserve access to mifepristone under the current rules in 17 Democratic-led states and the District of Columbia that filed a separate lawsuit.

The Biden administration has said the rulings conflict and create an untenable situation for the FDA.

In an order issued last Friday by Justice Samuel Alito, the court put the restrictions on hold through Wednesday to give the court time to consider the emergency appeal.

If the justices aren’t inclined to block the ruling from taking effect for now, the Democratic administration and Danco have a fallback argument, asking the court to take up the challenge to mifepristone, hear arguments and decide the case by early summer.

The court only rarely takes such a step before at least one appeals court has thoroughly examined the legal issues involved.

The 5th U.S. Circuit Court of Appeals in New Orleans already has ordered an accelerated schedule for hearing the case, with arguments set for May 17.

Mifepristone has been available for use in medication abortions in the United States since the FDA granted approval in 2000. Since then, more than 5 million women have used it, along with another drug, misoprostol, to induce abortions.
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