Pfizer: 3-shot regime protects youngest
Company closer to offering covid-19 vaccination for kids younger than 5 years
Three doses of Pfizer’s covid-19 vaccine offer strong protection for children younger than 5, the company announced Monday, another step toward shots for the youngest kids.
Pfizer plans to submit the findings to U.S. regulators later this week. The Food and Drug Administration already is evaluating an application by rival Moderna to offer two-dose vaccinations to kids — and set June 15 as a tentative date for its independent scientific advisers to publicly debate the data from one or both companies.
The 18 million children under 5 are the only group in the U.S. not yet eligible for covid-19 vaccination.
Pfizer aims to give youths 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 the children’s 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.
If FDA confirms the data, the vaccine could “be an important tool to help parents protect their children,” said Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief. But he cautioned that it’s essential to track how long protection lasts, especially against serious disease.
FDA vaccine chief Dr. Peter Marks pledged the agency will “move quickly without sacrificing our standards” in evaluating tot-sized doses from Pfizer and Moderna.
Moderna asked FDA to authorize two shots, each containing a quarter of the dose given to adults. While that spurred good levels of virus-fighting antibodies, Moderna’s study found effectiveness against symptomatic covid-19 was just 40% to 50% during the omicron surge, much like for adults who’ve only had two vaccine doses.
“We’ve learned in older children and adults that … we really need three doses to get protection” against newer variants like omicron, said Dr. William Moss of the Johns Hopkins Bloomberg School of Public Health, who was not part of the study.
That’s something Moderna plans to study, and Moss said he didn’t expect the question would hold up FDA authorization of the first two doses.
Complicating Moderna’s progress, the FDA so far has allowed its vaccine to be used only in adults. The company also is seeking FDA authorization for teens and elementary-age kids.
The FDA has tentatively planned for its expert panel to consider Moderna’s vaccine for older kids a day before taking up the question of shots for the littlest.
If FDA clears either vaccine or both, the Centers for Disease Control and Prevention would have to recommend whether all kids under 5 should receive the shots or only those at high risk.
While covid-19 generally isn’t as dangerous to youngsters as to adults, some children do become severely ill or even die. 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 for the best protection against the latest coronavirus variants.
PHILADELPHIA SCHOOLS MASK UP
As students and teachers in Philadelphia returned to school Monday, they had to wear masks once again, as coronavirus cases continue to rise.
William Hite Jr., the superintendent of the Philadelphia School District, announced Friday that “all school district students and staff will be required to wear their masks during the school and work day and while riding on school buses and vans” until further notice.
The superintendent emphasized that the district was remaining flexible to adjust to new threats from covid-19.
“The coronavirus continues to evolve and so too will our response to it,” he said in a statement.
Coronavirus cases in the Philadelphia area are trending in the same direction as in the nation.
Philadelphia County most recently had an average of 434 new cases reported per day, a 42% increase from the average two weeks earlier, according to a New York Times database. It had 209 new hospitalizations reported per day, a 29% jump from the average two weeks earlier.
HEALTH CARE STAFF BURNOUT
Vice President Kamala Harris and U.S. Surgeon General Dr. Vivek Murthy issued a warning Monday about burnout among the nation’s health care staff after more than two years of the covid-19 pandemic.
“You do so much to take care of your patients in their time of need,” Harris told health care workers Monday as she visited Children’s National Hospital in Washington with Murthy. “We need to do a better job of taking care of you.”
Murthy issued a new report sounding the alarm over a projected shortage of 3 million “essential low-wage health workers” in the next five years, and nearly 140,000 doctors by 2033.
“People are really struggling,” Murthy said. “After two years of covid-19 and more than 1 million precious lives lost, the people we all turn to to keep us safe, to comfort us and help us heal, they have been pushed to their limits.”
The administration is calling for new investments and steps to protect the mental well being of health care workers. That includes expanding counseling offerings, reducing administrative burdens and promoting worker safety on the job.
Unless changes are made, Murthy said, the country will be less prepared for future public health emergencies and “we will send a message to millions of healthcare workers that their suffering does not matter.”