Three doses of Pfizer’s COVID-19 vaccine offer strong protection for children younger than 5, the company announced Monday. Pfizer plans to give the data to U.S. regulators later this week in a step toward letting the littlest kids get the shots.
The news comes after months of anxious waiting by parents desperate to vaccinate their babies, toddlers and preschoolers, especially as COVID-19 cases once again are rising. The 18 million tots under 5 are the only group in the U.S. not yet eligible for COVID-19 vaccination.
The Food and Drug Administration has begun evaluating data from rival Moderna, which hopes to begin offering two kid-sized shots by summer.
Pfizer has had a bumpier time figuring out its approach. It aims to give tots an even lower dose — just one-tenth of the amount adults receive — but discovered during its trial that two shots didn’t seem quite strong enough for preschoolers. So researchers gave a third shot to more than 1,600 youngsters — from age 6 months to 4 years — during the winter surge of the omicron variant.
In a press release, Pfizer and its partner BioNTech said the extra shot did the trick, revving up tots’ levels of virus-fighting antibodies enough to meet FDA criteria for emergency use of the vaccine with no safety problems.
Preliminary data suggested the three-dose series is 80% effective in preventing symptomatic COVID-19, the companies said, but they cautioned the calculation is based on just 10 cases diagnosed among study participants by the end of April. The study rules state that at least 21 cases are needed to formally determine effectiveness, and Pfizer promised an update as soon as more data is available.
The companies already had submitted data on the first two doses to the FDA, and BioNTech’s CEO, Dr. Ugur Sahin, said the final third-shot data would be submitted this week.
“The study suggests that a low, 3-microgram dose of our vaccine, carefully selected based on tolerability data, provides young children with a high level of protection against the recent COVID-19 strains,” he said in a statement.
What’s next? FDA vaccine chief Dr. Peter Marks has pledged the agency will “move quickly without sacrificing our standards” in evaluating tot-sized doses from both Pfizer and Moderna.
The agency has set tentative dates next month for its scientific advisers to publicly debate data from each company.
Moderna is seeking to be the first to vaccinate the littlest kids. It submitted data to the FDA saying tots develop high levels of virus-fighting antibodies after two shots that contain a quarter of the dose given to adults. The Moderna study found effectiveness against symptomatic COVID-19 was 40% to 50% during the omicon surge, much like for adults who’ve only had two vaccine doses.
Complicating Moderna’s progress, the FDA so far has allowed its vaccine to be used only in adults.
The FDA is expected to review Moderna’s data on both the youngest age group, plus its study of teens and elementary-age children. Other countries already have expanded Moderna’s shot to kids as young as 6.
While COVID-19 generally isn’t as dangerous to youngsters as to adults, some children do become severely ill or even die. And the omicron variant hit children especially hard, with those under 5 hospitalized at higher rates than at the peak of the previous delta surge.
It’s not clear how much demand there will be to vaccinate the youngest kids. Pfizer shots for 5- to 11-year-olds opened in November, but only about 30% of that age group have gotten the recommended initial two doses. Last week, U.S. health authorities said elementary-age children should get a booster shot just like everyone 12 and older is supposed to get, for the best protection against the latest coronavirus variants.
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
Vice President Kamala Harris and U.S. Surgeon General Dr. Vivek Murthy are warning of burnout among the nation’s health care staff after more than two years of the COVID-19 pandemic, including the potential for severe worker shortages in the years ahead if the situation is not addressed.
Harris and Murthy on Monday are visiting Children’s National Hospital in Washington to meet with health care providers and deliver remarks as Murthy unveils a report, “Surgeon General’s Advisory Addressing Health Worker Burnout.” It sounds the alarm over a projected shortage of “3 million essential low-wage health workers” in the next five years, as well as nearly 140,000 doctors by 2033.
“The nation’s health depends on the well-being of our health workforce. Confronting the long-standing drivers of burnout among our health workers must be a top national priority,” Murthy said in a statement. “COVID-19 has been a uniquely traumatic experience for the health workforce and for their families, pushing them past their breaking point. Now, we owe them a debt of gratitude and action. And if we fail to act, we will place our nation’s health at risk.”
The administration is calling for new investments and steps to protect the mental wellbeing of health care workers, including by expanding counseling offerings, reducing administrative burdens and promoting worker safety on the job.
The initiative comes as the Biden administration is mounting a nationwide push to address mental health issues. President Joe Biden unveiled a national strategy to expand mental health and drug abuse treatment during his State of the Union address in March.
President Joe Biden sought Monday to calm concerns about recent cases of monkeypox that have been identified in Europe and the United States, saying he did not see the need to institute strict quarantine measures.
Speaking in Tokyo a day after he said the virus was something “to be concerned about,” Biden said, ”I just don’t think it rises to the level of the kind of concern that existed with COVID-19.”
Monkeypox is rarely identified outside of Africa. But as of Friday, there were 80 confirmed cases worldwide, including at least two in the United States, and another 50 suspected ones. On Sunday, one presumptive case of monkeypox also was being investigated in Broward County in South Florida, which state health officials said appeared to be related to international travel.
Although the disease belongs to the same virus family as smallpox, its symptoms are milder. People usually recover within two to four weeks without needing to be hospitalized, but the disease occasionally is deadly.
Biden said the smallpox vaccine works for monkeypox. Asked whether the U.S. has enough stockpile of that vaccine to handle the monkeypox spread, Biden said, “I think we do have enough to deal with the likelihood of a problem.”
Total Doses Distributed = 741,676,155. Total Doses Administered = 584,279,990. Number of People Receiving 1 or More Doses = 258,149,591. Number of People Fully Vaccinated = 220,914,142.
Total Doses Distributed = 741,658,255. Total Doses Administered = 583,987,461. Number of People Receiving 1 or More Doses = 258,106,038. Number of People Fully Vaccinated = 220,878,432.
The White House is planning for “dire” contingencies that could include rationing supplies of vaccines and treatments this fall if Congress doesn’t approve more money for fighting COVID-19.
In public comments and private meetings on Capitol Hill, Dr. Ashish Jha, the White House coronavirus coordinator, has painted a dark picture in which the U.S. could be forced to cede many of the advances made against the coronavirus over the last two years and even the most vulnerable could face supply shortages.
Biden administration officials have been warning for weeks that the country has spent nearly all the money in the $1.9 trillion American Rescue Plan that was dedicated directly to COVID-19 response.
A small pool of money remains, and the administration faces critical decisions about how to spend it. That means tough decisions, like weighing whether to use it to secure the next generation of vaccines to protect the highest risk populations or giving priority to a supply of highly effective therapies that dramatically reduce the risks of severe illness and death.
That decision may be made in the coming week, according to the administration, as the White House faces imminent deadlines to begin placing orders for vaccines and treatments before other nations jump ahead of the U.S. in accessing supply.
Jha has warned that without more money, vaccines will be harder to come by, tests will once again be scarce, and the therapeutics that are helping the country weather the current omicron-driven surge in cases without a commensurate increase in deaths could be sold overseas before Americans can access them.
“I think we would see a lot of unnecessary loss of life if that were to happen,” Jha said this past week. “But we’re looking at all the scenarios and planning for all of them.”
He said the administration was “getting much more into the scenario-planning business to make sure that we know what may be ahead of us so we can plan for it and obviously also lay those out in front of Congress.”
Jha, who declined to put a specific projection on potential loss of life, has become the face of the Biden administration’s efforts to persuade Congress to approve an additional $22.5 billion for COVID-19 response.
“The scenarios that we’re planning for are for things like what if Congress gives us no money and we don’t have adequate vaccines,” Jha told the AP in a May 12 interview. “We run out of therapies. We don’t have enough tests. What might things look like? Obviously, that’s a pretty dire situation.”
Already, the domestic production of at-home testing is slowing, with workers beginning to be laid off. In the coming weeks, Jha said, manufacturers will sell off equipment and “get out of this business,” leaving the U.S. once again dependent on overseas suppliers for rapid test.
Drug manufactures and the Food and Drug Administration, meanwhile, are working on evaluating the next generation of vaccines, potentially including ones that are targeted at the dominant omicron strain. But getting them ready before the predicted case surge in the fall means placing orders now, since they take two to three months to produce.
Jha said this week that the U.S. has yet to start negotiations with drugmakers because of the lack of money.
“We’ve had some very preliminary conversations with the manufacturers,” he said. “But the negotiations around it have not yet begun, partly because we’re waiting for resources.” He added: “The truth is that other countries are in conversations with the manufacturers and starting to kind of advance their negotiations.”
The U.S., he said, doesn’t have enough money to purchase additional booster vaccines for anyone who wants one. Instead, the supplies of those vaccines may be restricted to just the most vulnerable — not unlike the chaotic early days of the COVID-10 vaccine roll-out.
“Without additional funding from Congress, we will not be able to buy enough vaccines for every American who wants one once these new generation of vaccines come out in the fall and winter,” he said.
And while the U.S. has built up a stockpile of the antiviral pill Paxlovid, which has been widely effective at reducing severe disease and death, it’s running out of money to purchase new doses — or other, even more effective therapies that are in the final stages of development.
“If we don’t get more resources from Congress, what we will find in the fall and winter is we will find a period of time where Americans can look around and see their friends in other countries — in Europe and Canada — with access to these treatments that Americans will not have,” Jha said.
A congressional deal for a slimmed-down COVID-19 response package of about $10 billion fell apart in March over the Biden administration’s plans to lift virus-related restrictions on migration at U.S. borders. But a federal judge on Friday put that plan on hold, just days before it was to take effect on Monday.
There is no guarantee of swift action on Capitol Hill, where lawmakers — particularly Republicans — have grown newly wary of deficit spending. On Thursday, a $40 billion measure to assist restaurants that struggled during the pandemic failed on those grounds. GOP lawmakers have also objected to additional funding for the global pandemic response, and called for any new virus response funding to come from unspent economic relief money in the $1.9 trillion rescue plan.
The administration is preparing to lay the blame on lawmakers if there are tough consequences this fall due to lack of money. Still, it could be perilous for Biden, who has struggled to fulfill his promise to voters to get control of the pandemic.
