A federal judge in Texas on Friday ordered a hold on U.S. approval of the abortion medication mifepristone, throwing into question access to the nation’s most common method of abortion in a ruling that waved aside decades of scientific approval.The immediate impact of the ruling by U.S. District Judge Matthew J. Kacsmaryk, which does not go into immediate effect, was unclear.The abortion drug has been widely used in the U.S. since 2000 and there is essentially no precedent for a lone judge overruling the medical decisions of the Food and Drug Administration. Mifepristone is one of two drugs used for medication abortion in the United States, along with misoprostol, which is also used to treat other medical conditions.Kacsmaryk, a Trump administration appointee in Amarillo, Texas, signed an injunction directing the FDA to stay mifepristone’s approval while a lawsuit challenging the safety and approval of the drug continues. His 67-page order gave the government seven days to appeal.“Simply put, FDA stonewalled judicial review — until now,” Kacsmaryk wrote.He didn’t go as far as the plaintiffs wanted by withdrawing or suspending the approval of the chemical abortion drug and removing it from the list of approved drugs. But he put a “stay” or hold on approval of the drug.Federal lawyers representing the FDA are expected to swiftly appeal.Clinics and doctors that prescribe the two-drug combination have said that if mifepristone were pulled from the market, they would switch to using only the second drug, misoprostol. That single-drug approach has a slightly lower rate of effectiveness in ending pregnancies, but it is widely used in countries where mifepristone is illegal or unavailable.Mifepristone is part of a two-drug regimen that has long been the standard for medication abortion in the U.S. Clinics and doctors that prescribe the combination say they plan to switch to using only misoprostol. The single-drug approach is slightly less effective at ending pregnancies.The lawsuit was filed by the Alliance Defending Freedom, which was also involved in the Mississippi case that led to Roe v. Wade being overturned. At the core of the lawsuit is the allegation that the FDA’s initial approval of mifepristone was flawed because it did not adequately review its safety risks.Courts have long deferred to the FDA on issues of drug safety and effectiveness. But the agency’s authority faces new challenges in a post-Roe legal environment in which abortions are banned or unavailable in 14 states, while 16 states have laws specifically targeting abortion medications.

The U.S. is expanding COVID-19 boosters as it confronts the omicron surge, with the Food and Drug Administration allowing extra Pfizer shots for children as young as 12.Boosters already are recommended for everyone 16 and older, and federal regulators on Monday decided they’re also warranted for 12- to 15-year-olds once enough time has passed since their last dose.But the move, coming as classes restart after the holidays, isn’t the final step. The Centers for Disease Control and Prevention must decide whether to recommend boosters for the younger teens. Dr. Rochelle Walensky, the CDC’s director, is expected to rule later this week.The FDA also said everyone 12 and older eligible for a booster can get one as early as five months after their last dose rather than six months.Vaccines still offer strong protection against serious illness from any type of COVID-19. But health authorities are urging everyone who’s eligible to get a booster dose for their best chance at avoiding milder breakthrough infections from the highly contagious omicron mutant.Children tend to suffer less serious illness from COVID-19 than adults. But child hospitalizations are rising during the omicron wave — most of them unvaccinated.The vaccine made by Pfizer and its partner BioNTech is the only U.S. option for children of any age. About 13.5 million 12- to 17-year-olds — just over half that age group — have received two Pfizer shots, according to the CDC.For families hoping to keep their children as protected as possible, the booster age limit raised questions.The older teens, 16- and 17-year-olds, became eligible for boosters in early December. But original vaccinations opened for the younger teens, those 12 to 15, back in May. That means those first in line in the spring, potentially millions, are about as many months past their last dose as the slightly older teens.As for even younger children, kid-size doses for 5- to 11-year-olds rolled out more recently, in November — and experts say healthy youngsters should be protected after their second dose for a while. But the FDA also said Monday that if children that young have severely weakened immune systems, they will be allowed a third dose 28 days after their second. That’s the same third-dose timing already recommended for immune-compromised teens and adults.Pfizer is studying its vaccine, in even smaller doses, for children younger than 5.

Video above: Doctor talks about possibility of Moderna COVID-19 vaccine use in kids ages 12-15Moderna announced Tuesday that it has initiated the rolling submission process with the Food and Drug Administration for full approval of its COVID-19 vaccine for people 18 years and older. "We are pleased to announce this important step in the U.S. regulatory process for a Biologics License Application (BLA) of our COVID-19 vaccine," said Stéphane Bancel, Chief Executive Officer of Moderna. "We look forward to working with the FDA and will continue to submit data from our Phase 3 study and complete the rolling submission."Last month, Moderna said its vaccine strongly protects kids as young as 12, a step that could put the shot on track to become the second option for that age group in the U.S. Pfizer's COVID-19 vaccine has received emergency use approval for children as young as 12.Moderna says will continue to submit data to support the BLA to the FDA on a rolling basis over the coming weeks.

Doctors are expecting kids as young as 12 years old to be getting the Pfizer vaccine locally as soon as Wednesday or Thursday after the Food and Drug Administration made it available through new emergency approval.The Centers for Disease Control and Prevention and the states have to sign off on the approval which is expected to happen very quickly.“Having the vaccine available now for 12 and above is going to really be a big step forward to make our return to normal much quicker,” Dr. Robert Frenck said.Frenck led the Pfizer trials for adults at Cincinnati Children’s Hospital and is now working on research on children down to age 5.“I’m really excited about having the vaccine available for 12 and above. I’m going to be more excited when we have it for younger children,” Frenck said.Frenck expects the vaccine for those ages 5 to 11 to be approved by the fall.The biggest impact of the approval is that many parents are now facing the decision to vaccinate their children.Cincinnati Children’s chief of staff Patty Manning said the benefits of the vaccine far outweigh the risks.The American Pediatrics Association numbers show 3.8 million kids have had COVID-19, 15,000 have been hospitalized, more than 300 have died.Cincinnati is not immune to the trends.“Every day here at Children’s Hospital, since I can’t remember when, we’ve had at least one, if not many children hospitalized with COVID. That is the reality,” Manning said. “We can’t promise you, neither Dr. Frenck nor myself could ever promise you your child won’t get COVID and that it wouldn’t be serious, But we can promise you with the vaccine the chance of that happening is significantly reduced.”