Pfizer says shots safe in kids
Firm notes efficacy of vaccine for ages 12-15
Pfizer announced Wednesday that its covid-19 vaccine is safe and strongly protective in kids as young as 12, a step toward possibly beginning shots in that age group before the children head back to school in the fall.
Most covid-19 vaccines being rolled out worldwide are for adults, who are at higher risk from the disease caused by the coronavirus. Pfizer’s vaccine is authorized for ages 16 and older. But vaccinating children of all ages will be critical to stopping the pandemic — and helping schools, at least the upper grades, start to look more normal after months of disruption.
In the vaccine study of 2,260 U.S. volunteers ages 12 to 15, preliminary data showed there were no cases of covid-19 among fully vaccinated adolescents compared with 18 among those given dummy shots, Pfizer reported. Researchers reported high levels of virus-fighting antibodies, somewhat higher
than were seen in studies of young adults.
Kids had side effects similar to young adults, the company said. The main side effects are pain, fever, chills and fatigue, particularly after the second dose. The study will continue to track participants for two years for more information about long-term protection and safety.
Dr. Philip J. Landrigan of Boston College said the results are encouraging.
“It’s hard to get kids to comply with masking and distancing, so something that gives them hard protection and takes them out of the mix of spreading the virus is all for the good,” said Landrigan, who was not involved in the study.
It’s another positive development in the race against the virus even as U.S. cases, at 66,000 new infections a day, are rising again and as deaths are averaging nearly 1,000 a day. Centers for Disease Control and Prevention Director Dr. Rochelle Walensky warned Americans again Wednesday that “we can’t afford to let our guard down.”
Pfizer and German partner BioNTech in the coming weeks plan to ask the U.S. Food and Drug Administration and European regulators to allow emergency use of the shots starting at age 12.
“We share the urgency to expand the use of our vaccine,” Pfizer CEO Albert Bourla said in a statement. He expressed “the hope of starting to vaccinate this age group before the start of the next school year” in the United States.
Pfizer isn’t the only company seeking to lower the age limit for its vaccine. Results are expected by the middle of this year from a U.S. study of Moderna’s vaccine in 12- to 17-year-olds.
The FDA has already allowed both companies to begin U.S. studies in children 11 and younger, working their way to as young as 6 months old.
AstraZeneca in February began a study of its vaccine among 6- to 17-year-olds in Britain. Johnson & Johnson is planning its own pediatric studies. And in China, Sinovac recently announced it has submitted preliminary data to Chinese regulators showing its vaccine is safe in children as young as 3.
While most covid-19 vaccines being used globally were first tested in tens of thousands of adults, pediatric studies won’t need to be nearly as large. Scientists have safety information from those studies and from subsequent vaccinations in millions more adults.
One key question is the dosage: Pfizer gave the 12-and-older participants the same dose adults receive, while testing different doses in younger children.
It’s not clear how quickly the FDA would act on Pfizer’s request to allow vaccination starting at age 12. The agency has taken about three weeks to review and authorize each of the vaccines currently available for adults. That process included holding a public meeting of outside experts to review and vote on the safety and effectiveness of each vaccine.
The process for reviewing data in children could be shorter, given the FDA’s familiarity with each vaccine. An agency spokeswoman said the FDA had no information to share on how the review would work, including whether additional public meetings would be required.
Another question is when the country would have enough supply of shots — and people to get them into adolescents’ arms — to let kids start getting in line.
Supplies are set to steadily increase over the spring and summer, at the same time states are opening vaccinations to younger, healthier adults.
Children represent about 13% of covid-19 cases documented in the U.S. And while children are far less likely than adults to get seriously ill, at least 268 have died from covid-19 in the U.S. and more than 13,500 have been hospitalized, according to a tally by the American Academy of Pediatrics. That’s more than the number who die from the flu in an average year. Additionally, a small number have developed a serious inflammatory condition linked to the coronavirus.
U.S. DEATHS
Additionally, the CDC reported Wednesday that the covid-19 pandemic pushed total U.S. deaths last year beyond 3.3 million, the nation’s highest single-year death toll.
The coronavirus caused approximately 375,000 deaths and was the third-leading cause of death in 2020, after heart disease and cancer. Covid-19 deaths in the U.S. now top 550,000 since the start of the pandemic.
Covid-19 displaced suicide as one of the top 10 causes of death, according to the report from the CDC.
“The data should serve again as a catalyst for each of us to continue to do our part to drive down cases and reduce the spread of covid-19 and get people vaccinated as quickly as possible,” Walensky said Wednesday.
The U.S. death toll increases most years, but last year’s death rate was up nearly 16% compared with the previous year. That’s the largest oneyear leap since 1918, when U.S. soldier deaths in World War I and the flu pandemic pushed deaths up 46% compared with 1917.
Death rates last year overall were highest among Black people and American Indian and Alaska Native people. The covid-19 death rate was highest among Hispanic people.
“Sadly, based on the current state of the pandemic, these impacts have remained in 2021 where we continue to see that communities of color account for an outsize portions of these deaths,” Walensky said.
DOSES RUINED
In other virus news, workers at a Baltimore plant manufacturing two coronavirus vaccines accidentally conflated the vaccines’ ingredients several weeks ago, ruining about 15 million doses of Johnson & Johnson’s vaccine and forcing regulators to delay authorization of the plant’s production lines.
The plant is run by Emergent BioSolutions, a manufacturing partner to both Johnson & Johnson and AstraZeneca. Federal officials attributed the mistake to human error.
The mix-up has halted future shipments of Johnson & Johnson doses in the United States while the FDA investigates. Johnson & Johnson has moved to strengthen its control over Emergent BioSolutions’ work to avoid further quality lapses.
The mistake is a major embarrassment for Johnson & Johnson, whose one-dose vaccine has been credited with speeding up the national immunization program.
It does not affect Johnson & Johnson doses that are currently being delivered and used nationwide. All of those doses were produced in the Netherlands, where operations have been fully approved by federal regulators.
But all further shipments of the Johnson & Johnson vaccine — projected to total tens of millions of doses this month — were supposed to come from the Baltimore plant.
Those shipments are now in question while the quality control issues are sorted out, according to people familiar with the matter.
Federal officials still expect to have enough doses to meet President Joe Biden’s commitment to provide enough vaccine by the end of May to immunize every adult. The two other federally authorized manufacturers, Pfizer and Moderna, are continuing to deliver as expected.
DEBATE IN EUROPE
Meanwhile, the head of the European Medicines Agency said Wednesday that there is “no evidence” that would support restricting the use of AstraZeneca’s coronavirus vaccine in any population, as Germany has now done amid concerns over rare blood clots in people who got the shot.
But the agency’s executive director, Emer Cooke, said her Amsterdam-based agency continues to study reports of new cases as they come in and will provide a further assessment next week.
On Tuesday, an independent vaccine-expert panel in Germany said AstraZeneca shots should not routinely be given to people under 60 because of a rise in reported cases of unusual blood clots in the days after vaccination.
The German government followed the recommendation and said the British-Swedish company’s vaccine would be prioritized for people age 60 and older, although exceptions can be made in consultation with doctors.
The move put the spotlight back on the European Medicines Agency, which authorized the AstraZeneca vaccine in January and said last month — after some European countries suspended its use over blood clot fears — that the vaccine’s benefits outweigh the risks.
“According to the current scientific knowledge, there is no evidence that would support restricting the use of this vaccine in any population,” Cooke told reporters.
She said the agency’s assessment was based on 62 cases worldwide of unusual blood clots, including 14 deaths, reported to the agency by March 22. Those figures included a “significant” number of the cases reported from Germany, but not all, she said.
German regulators said they had received 31 reports of rare blood clots in the head in recipients of the AstraZeneca vaccine and nine deaths up to Monday, roughly doubling the number that had been reported in the country by March 22.
Cooke said the agency will include the German cases in its review, “and they will form part of the ongoing evaluation that the committee is undertaking, as will any additional cases that are reported from other countries and regions.”