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 this age group before they 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 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 a little more normal after months of disruption.

In a 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 to 18 among those given dummy shots, Pfizer reported.

It’s a small study, that hasn’t yet been published, so another important piece of evidence is how well the shots revved up the kids’ immune systems. 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.

Pfizer and its 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 also are expected by the middle of this year from a U.S. study of Moderna’s vaccine in 12- to 17-year-olds.

But in a sign that the findings were promising, the FDA already allowed both companies to begin U.S. studies in children 11 and younger, working their way to as young as 6-month-old.

“We are longing for a normal life. This is especially true for our children,” BioNTech CEO Ugur Sahin said in a statement.

AstraZeneca last month 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 of 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 shot.

The process for reviewing data in children could be shorter, given 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 who until now haven’t had a turn.

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. alone and more than 13,500 have been hospitalized, according to a tally by the American Academy of Pediatrics. That’s more than die from the flu in an average year. Additionally, a small number have developed a serious inflammatory condition linked to the coronavirus.

Caleb Chung, who turns 13 later this week, agreed to volunteer after his father, a Duke University pediatrician, presented the option. He doesn’t know if he received the vaccine or a placebo.

“Usually I’m just at home doing online school and there’s not much I can really do to fight back against the virus,” Caleb said in a recent interview. The study “was really somewhere that I could actually help out.”

His father, Dr. Richard Chung, said he’s proud of his son and all the other children volunteering for the needle pricks, blood tests, and other tasks a study entails.

“We need kids to do these trials so that kids can get protected. Adults can’t do that for them,” Chung said.

Source: www.click2houston.com

President Joe Biden and a top health official warned Monday that too many Americans are declaring virus victory too quickly, appealing for mask requirements and other restrictions to be maintained or restored to stave off a “fourth surge” of COVID-19. The head of the CDC said she had a feeling of “impending doom” if people keep easing off.

The double dose of warnings came even as Biden laid out hopeful new steps to expand coronavirus vaccinations, with all adults to become eligible over the next 5 weeks. Biden announced plans to expand the number of retail pharmacies that are administering vaccines, and investments to help Americans get to vaccination sites. But the optimism was tempered by stark warnings about the potential for another wave of cases.

“This is deadly serious,” Biden said, urging governors to reinstate mask mandates and other restrictions that some states have been easing.

Hours earlier, during a virtual White House health briefing, Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, grew emotional as she reflected on her experience treating COVID-19 patients who are alone at the end of their lives.

“We have so much to look forward to, so much promise and potential of where we are and so much reason for hope,” she said. “But right now, I’m scared.”

“I’m going to lose the script, and I’m going to reflect on the recurring feeling I have of impending doom.”

Cases of the virus are up about 10% over the past week from the previous week, to about 60,000 cases per day, with both hospitalizations and deaths ticking up as well, Walensky said. She warned that without immediate action the U.S. could follow European countries into another spike in cases and suffer needless deaths.

“I have to share the truth, and I have to hope and trust you will listen,” she said.

Later Monday, Biden addressed the nation from the White House, declaring, “If we let our guard down now, we can see the virus getting worse, not better. People are letting up on precautions, which is a very bad thing.”

Biden delivered a direct appeal to governors, state, and local leaders to reinstate mask-wearing requirements if they have lifted them, and said he encouraged leaders to pause plans to further ease virus-related restrictions.

“Please, this is not politics, reinstate the mandate if you let it down,” he said.

Biden announced that by April 19 at least 90% of the adult U.S. population would be eligible for vaccination — and would have access to a vaccination site within 5 miles of home. Quick vaccination would still depend on supply.

Biden had previously directed that all states make all adults eligible for vaccination by May 1, but many have moved to lift eligibility requirements sooner in anticipation of supply increases.

Meanwhile, the White House is moving to double the number of pharmacies participating in the federal retail pharmacy program — which has emerged as among the most efficient avenues for administering vaccines — and increase the number of doses for them to deliver. Retail pharmacies are located relatively close to most Americans and have experience delivering vaccines like flu shots.

Biden announced that the U.S. is expecting delivery of 33 million doses of the COVID-19 vaccine this week — including 11 million of the single-dose Johnson & Johnson shot.

More than one in five adults and nearly 50% of senior Americans are fully vaccinated, according to data from the CDC. On Thursday, the U.S. set a new single-day record for shots in arms: more than 3.2 million.

“Now is not the time to let down,” Biden said. “Now’s not the time to celebrate. It is time to do what we do best as a country: our duty, our jobs, take care of one another.”

“Fight to the finish,” he added. “Don’t let up now.”

Walensky and Dr. Anthony Fauci, the nation’s top infectious disease expert, appealed to elected officials, community leaders, and everyday Americans to maintain social distancing measures and mask-wearing.

“We are doing things prematurely,” Fauci said, referring to moves to ease up on restrictions. Walensky appealed to Americans, “Just please hold on a little while longer.”

She added: “We are not powerless, we can change this trajectory of the pandemic.”

Walensky pointed to an uptick in travel and loosening virus restrictions for the increase in cases. “People want to be done with this. I, too, want to be done with this,” she said.

“We’ve seen surges after every single holiday,” she reiterated: “Please limit travel to essential travel for the time being.”

The White House meanwhile is ruling out the creation of a national “vaccine passport” for Americans to verify their immunization status, saying it is leaving it to the private sector to develop a system for people to show they’ve been vaccinated. Some other countries are establishing national databases to allow vaccinated people to resume normal activities.

“We do know that there is a segment of the population that is concerned that the government will play too heavy-handed of a role in monitoring their vaccinations,” said White House COVID-19 adviser Andy Slavitt. He said officials are worried that “it would discourage people” from getting vaccinated if the federal government was involved.

The administration, instead, is developing guidelines for such passports, touching on privacy, accuracy, and equity, but the White House has not said when those guidelines will be ready.

Source: www.click2houston.com