Millions are desperate to get their hands on fever-reducing drugs and antivirals such as Pfizer’s Paxlovid as infections across China outpace supplies.
Federal officials are hoping that the encouraging results will spur more Americans to get an updated booster before a feared surge in coronavirus cases this winter.
Regulators authorized the shots for older age groups in late August, but much of the general population appears either unaware or uninterested in them.
The lawsuit, filed Friday, alleges that the companies’ Covid vaccine violated Moderna’s mRNA patents.
The vaccines seem safe for children and are likely to protect against severe illness. But data on efficacy are thin, and most children have already been infected.
A recommendation from the C.D.C. director would be the final step before doses are rolled out for the roughly 20 million children under the age of 5.
Some scientists believe that a clearer picture of Covid vaccine efficacy could have emerged sooner if investigators had tracked certain immune cells, not just antibodies.
States have already ordered millions of doses; if the agency authorizes them in the coming days, babies, toddlers and preschoolers could start receiving shots next week.
Outside experts will make their recommendations this week on how the agency should rule on applications from Pfizer and Moderna to vaccinate the nation’s youngest children.
A third dose would enhance immunity to the coronavirus, the agency said. But hesitancy is high, and less than one-third of children in this age group have received two doses.
More than eight million of the 28 million children in that age group in the United States have received two vaccine shots.
Given that the age group has the lowest coronavirus vaccination rate of all eligible Americans, public health experts are not expecting a rush for the booster.
Both Moderna and Pfizer-BioNTech have asked the agency to approve their vaccines for the youngest children.
Pfizer and BioNTech will soon ask the Food and Drug Administration for emergency authorization of Covid booster doses for that age group, the companies said.
People in the age group can get the additional shot at least four months after their first booster. Those 12 and older with certain immune deficiencies are also eligible.
Federal officials appear to be coalescing around a plan to offer people 65 and older — and possibly some younger adults — the option of another booster, in case infections surge again soon.
Given the surge of Omicron cases in Asia, the new research lends urgency to vaccination campaigns in China and Hong Kong.
The company said the vaccine produced a strong immune response in children younger than 6, but proved only about 40 percent effective in preventing symptomatic Covid-19.
The move could further inflame a tortuous debate among scientists over when the coronavirus vaccines’ protection should be bolstered, and for whom.
Once dismissed as less effective, the vaccine now seems to be preventing infections and illness about as well as the two mRNA options.
Moderna is going head-to-head with Pfizer-BioNTech for the opportunity to vaccinate the youngest children, the only Americans still not eligible for shots.
Beijing once said it had two mRNA shots within reach and ready for approval — one homemade and one produced by a foreign company. Today, neither are available.
A Food and Drug Administration official said the best time for an additional shot may be fall, when the spread of the coronavirus is expected to pick up again
Here’s what families should know about the delay.
The agency will wait for data on whether three doses of Pfizer-BioNTech’s Covid vaccine are effective in young children after new, disappointing data.
It’s not clear whether three doses of the Pfizer-BioNTech vaccine will adequately protect young children. But the F.D.A. may authorize the first two doses anyway.
It’s confusing, but don’t freak out.
The reports, both released on Thursday, underscored the importance of vaccinating children against the coronavirus.
Regulators will also allow even younger children with immune deficiencies to get an extra shot.
The company’s finding is based on only a small study of blood samples in a laboratory, but others are sure to follow.
As infections rise, Americans over 18 will be permitted to get extra doses. But it’s not clear boosters really are needed by so many people, or that the shots will turn back the pandemic.
Regulators are set to clear extra doses of Pfizer-BioNTech’s vaccine as soon as Thursday, after states began expanding eligibility on their own.
In a turnaround, the agency is expected to grant the request before the winter holiday season, giving access to all 181 million fully vaccinated people.
Every child 5 years and older is now eligible, but getting an appointment may take a little patience.
With the agency director’s sign-off, children ages 5 to 11 could begin to receive the shots this week.
The latest data is reassuring. Myocarditis remains very uncommon, and it is almost always mild and temporary. The heart risk from Covid-19 itself is far greater.
“In our hearts, I think people don’t quite agree with this notion of a booster dose,” said one leading vaccine expert.
The findings could add momentum for F.D.A. authorization of the pediatric dose, perhaps as early as next week, a long-awaited development that would affect 28 million children.
Recipients of the Moderna and the J.&J. vaccines may receive extra doses, although the shots continue to prevent illness and death.
The agency will also allow vaccine recipients to pick which vaccine they want as a booster, endorsing a mix-and-match approach.
Confused about who can get a booster shot of which vaccine, and what the F.D.A.’s advisers on vaccines are voting on this week? This scorecard may help.
Fragmented rules about which vaccines will be accepted and what documentation is needed, as well as a lack of compatibility between vaccine apps, have left many travelers frustrated.
The companies said that their vaccine was safe and effective in that age group, and that they would submit a formal request in the coming weeks to U.S. regulators to allow a pediatric dose.
Health officials were preparing on Friday to start giving booster shots to older and at-risk Americans, trying to make sense of new and broad eligibility guidelines.
Scientific advisers to the C.D.C. endorsed additional doses of the Pfizer-BioNTech vaccine for older Americans but not for health care workers, in a possible rift with regulators.
A series of studies found that the Moderna vaccine seemed to be more protective over the long term than the Pfizer-BioNTech vaccine. Here’s why.
Vaccinated kids aged 5 to 11 showed evidence of protection against the virus, the company said. The data must be reviewed by the F.D.A. before children can be inoculated.
As rich countries ponder the marginal utility of third doses, billions of people around the world are still waiting for their first.
Congress appropriated $16 billion to ramp up Covid-19 countermeasures, but a new report found that the Biden administration had spent very little of it on expanding vaccine manufacturing capacity.