FDA authorizes first Covid-19 vaccine for younger kids

Parents should not wait to get their younger children vaccinated, acting US Food and Drug Administration commissioner Dr. Janet Woodcock said Friday.

The FDA gave emergency use authorization to Pfizer’s Covid-19 vaccine for 5-11 year-olds Friday and Woodcock urged parents to get their children vaccinated right away if the US Centers for Disease Control and Prevention signs off on the EUA next week.

Vaccinations aren’t just about protecting the individual, Woodcock said, they can help protect the community.

A Kaiser Family Foundation poll found on Thursday that the majority of parents say they do not plan to vaccinate their children ages 5 to 11 right away, and instead plan to wait and see how the vaccine is working for other people or not to vaccinate them at all.

Dr. Peter Marks

Covid-19 vaccines for the youngest children are still likely a few months off, a top US Food and Drug Administration official said Friday.

The FDA gave emergency use authorization for a one-third dose of Pfizer’s Covid-19 vaccine to children 5-11 on Friday. It will be a while longer before studies are complete for children under 5, Dr. Peter Marks, the director of the US Food and Drug Administration’s Center for Biologics Evaluation and Research, told reporters.

The FDA and the US Centers for Disease Control and Prevention will be keeping a close eye on all children both in clinical trials and in the real world getting these vaccines, Marks said, to make sure there aren’t rare side effects that only become apparent when many people receive them.

“Even with 3,000 children, that’s a large number, but very rare side effects sometimes become known later on and so we want to always be able to pick those up and then inform the public if there’s an issue,” Marks said.

Dr. Janet Woodcock, the acting US Food and Drug Administration commissioner, said Friday that the FDA anticipates that children in the 5 to 11 age group will be able to get vaccinated following next week’s meeting of the US Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices that will discuss clinical recommendations for this age group.

The FDA issued an emergency use authorization on Friday for Pfizer’s Covid-19 vaccine for children 5 to 11. This is the first Covid-19 vaccine authorized in the US for younger children.

“Parents and guardians can rest assured that we conducted [a] comprehensive and rigorous evaluation of the data on the vaccine safety and effectiveness,” Woodcock said.

Pfizer says data from the clinical trial shows the vaccine provides more than 90% protection against symptomatic disease among children of this age group.

While many children have only had mild cases of Covid-19, Woodcock said it was important to understand that more than 1.9 million children 5 to 11-years-old have gotten sick and more than 8,300 of them have been hospitalized through September of this year. Half of those children who were hospitalized did not have underlying health conditions.

“Vaccines are one of our greatest tools in the fight against this pandemic. Making sure younger children in our population now have access to them has been one of our highest priorities,” Woodcock said.

Wyoming Attorney General Bridget Hill has joined a 10-state coalition led by Missouri in filing a lawsuit against the BidenAdministration for imposing a vaccine mandate on federal contractors and federally contracted employees, according to a press statement released by Gov. Mark Gordon’s office Friday.

The lawsuit takes issue with the Biden administration’s use of federal procurement statutes to mandate vaccinations through Executive Order 14042, according to the statement.

The coalition alleges, “The Sept. 2, 2021, executive order enacted by the Biden Administration usurps the state’s police powers, violates the Tenth Amendment and federalism, violates the Procurement Act, violates the Administrative Procedures Act, and is an unconstitutional exercise of spending power,” according to the statement.

Joining Wyoming and Missouri in the lawsuit are Alaska, Arkansas, Iowa, Montana, Nebraska, New Hampshire, North Dakota, and South Dakota.

Some context: Florida Gov. Ron DeSantis announced that his state has officially filed a new lawsuit in Tampa against the Biden administration over the President’s same order, scheduled to take effect Dec. 8.

The White House responded to DeSantis’ announcement by saying “vaccine requirements work” and that Biden has the authority to mandate them.

In addition to the regular update of vaccination numbers on Friday, the US Centers for Disease Control and Prevention made updates to the vaccination data for Illinois and Kentucky that have affected the overall numbers, the agency told CNN. 

Updates to old data made by Illinois accounted for 316,351 Covid-19 vaccine doses administered. Data adjustments relating to how pharmacies report vaccination in Kentucky contributed a decrease of 411,224 doses administered. 

To note: As with Covid-19 statistics covering case and death rates, vaccination data is continually updated and occasional backdating and retroactive changes are made, like what is seen in Friday’s update. The numbers contained in this update are the most accurate currently.  

The changes in this update appear to have most affected the number of people newly vaccinated.

The data Friday shows a sharp drop from previous days, and should be taken in the context of current trends and the data changes mentioned above. As with every sharp turn seen in these numbers, it will take a couple days to know whether a change is indicative of a new trend.

Here’s latest data on vaccination efforts in the US, published Friday by the CDC:

Dr. William Gruber, Pfizer’s senior vice president of vaccine clinical research and development, called Friday “a great day” for the health of children after the US Food and Drug Administration authorized the company’s Covid-19 vaccine for children ages 5 to 11, saying the vaccine could have “a profound effect” on their lives and schools.

He added that the benefit of the vaccine wasn’t just to protect children themselves but those around them at home and in public.

“That is the benefit of preventing potential transmission, both in the school room settings: other children and their teachers and other providers in the school,” Gruber said. “And then of course, there’s the potential that if a child acquires infection in the schoolroom setting, they can bring it home to vulnerable loved ones, parents, grandparents, siblings, other individuals with underlying diseases that look into greater risk.” 

Some context: Shots can’t be administered until the US Centers for Disease Control and Prevention signs off – its vaccine advisers will meet Tuesday to consider whether to recommend the vaccine.

Gruber said vaccinating younger children was an important step toward ending the pandemic.

“We’re looking for more and more good chapters that take us to the end of the book, and in position where we can say Covid-19 is behind us at least as a pandemic illness,” he said.

Pfizer is continuing its Covid-19 vaccines studies in children as young as six months.

“We have work ongoing to extend the vaccines in even younger children and we hope to begin to provide some of that data by the end of this year and into next year,” he said, adding that it anticipates authorization for the youngest children to come sometime next year.

Doses of the Pfizer Covid-19 vaccine for children, in Puurs, Belgium.

The US Food and Drug Administration issued emergency use authorization on Friday for Pfizer’s Covid-19 vaccine for children ages 5 to 11. This is the first Covid-19 vaccine authorized in the United States for younger children. 

On Tuesday, the FDA’s vaccine advisers voted 17-0, with one abstention, to recommend EUA for the vaccine, which is formulated at one-third the dose of the vaccine used for people 12 and older.  

Pfizer says a clinical trial showed its vaccine provides more than 90% protection against symptomatic disease among children, even at one-third the dose, and the company hopes the lower dose will reduce the risk of any side effects.

What happens next: The question now goes to the US Centers for Disease Control and Prevention. The CDC’s vaccine advisers, the Advisory Committee on Immunization Practices, meet Nov. 2 to discuss whether to recommend use of the vaccine among US children. Then the CDC director, Dr. Rochelle Walensky, makes the final decision on use of the vaccine. 

The White House says it has a plan already in place for distributing vaccines to children. Vaccines could be administered as soon as the CDC signs off.

Pfizer’s Covid-19 vaccine was previously authorized for children ages 12 to 15. The vaccine is approved for people age 16 and older.

A pharmacist fills a syringe with the Pfizer Covid-19 vaccine on October 1, in San Rafael, California.

Vaccination protects people against coronavirus infection much better than previous infection, a team of researchers led by the US Centers for Disease Control and Prevention reported Friday. 

The team said their findings should help settle debates over whether people who have been infected should bother getting vaccinated. They should, the researchers said.

People who had not been vaccinated and who ended up in the hospital were five times more likely to have Covid-19 than people who had been vaccinated within the past three to six months, they found.

“We now have additional evidence that reaffirms the importance of COVID-19 vaccines, even if you have had prior infection,” CDC Director Dr. Rochelle Walensky said in a statement. 

“This study adds more to the body of knowledge demonstrating the protection of vaccines against severe disease from COVID-19. The best way to stop COVID-19, including the emergence of variants, is with widespread COVID-19 vaccination and with disease prevention actions such as mask wearing, washing hands often, physical distancing, and staying home when sick.” 

About the study: Researchers across the country collected data on 7,000 people treated at 187 hospitals in nine states for Covid-like illnesses between January and September. All were tested for coronavirus. Those who were not vaccinated were 5.49 times as likely to test positive for coronavirus as those who had been vaccinated within the past three to six months – even if they had a recent Covid-19 infection.

The CDC noted that a recent Israeli study found just the opposite—but also noted that the Israeli study looked at people who had been vaccinated six month before or longer. “Understanding infection-induced and vaccine-induced immunity over time is important, particularly for future studies to consider,” they wrote.

“In this study, the benefit of vaccination compared with infection without vaccination appeared to be higher for recipients of Moderna than Pfizer-BioNTech vaccine, which is consistent with a recent study that found higher vaccine effectiveness against COVID-19 hospitalizations for Moderna vaccine recipients than for Pfizer-BioNTech vaccine recipients,” they added.

Moderna announced a new agreement with Gavi, the Vaccine Alliance, to supply an additional 56.5 million Covid-19 vaccine doses for delivery in the second quarter of 2022, the company said Friday. 

This option for additional doses increases an agreement from earlier in the year for 60 million doses of Moderna’s vaccine, bringing the total to 116.5 million Covid-19 vaccine doses.

Under the agreement, 92 low- and middle-income countries are covered, according to a news release. These 92 countries are the Gavi COVAX Advance Market Commitment countries. 

Gavi has the option to procure 233 million additional doses in 2022, the release says. The doses are offered at the lowest price tier. 

New York City Fire Department members, New York Police Department members and other city workers have until 5 p.m. ET tonight to have proof that they’ve received at least one dose of vaccine or be placed on unpaid leave.

On Thursday, members of the FDNY opposed to the mandate crowded outside Gracie Mansion, the mayor’s official residence, to demonstrate, with some attendees carrying signs that read, “Essential Workers aren’t Disposable Heros (sic),” “My Body My Choice,” and “#Natural Immunity.”

“I’ve been working a year and a half with Covid, I haven’t gotten sick, I haven’t tested positive. I’ve been healthy the entire time. I don’t feel that I need the vaccine to survive,” Eyre said, adding he’s concerned about health risks stemming from the vaccine.

In an effort to mitigate the anticipated staffing problems, the fire department is planning to cancel vacations and enact mandatory overtime. The city’s medical services also will seek support by enacting mutual aid with private hospitals and volunteer ambulance services, per the source.

Mayor Bill de Blasio on Thursday offered assurances that emergency services will continue to function despite expected staff shortages, though he said he expected a rapid increase in vaccinations as the deadline approached, similar to what took place last month when a vaccine mandate went into effect for teachers and health care workers.

Boxes of Pfizer Covid-19 vaccine doses for children are packaged in Puurs, Belgium.

The US government has purchased an additional 50 million doses of Pfizer and BioNTech’s Covid-19 vaccine for younger children, Pfizer said in a news release on Thursday.

These additional doses are to “continue to support preparedness for pediatric vaccinations including securing vaccines for children under 5 years of age, should they receive regulatory authorization,” said the release.

The US Food and Drug Administration is currently considering whether to authorize the Pfizer/BioNTech Covid-19 vaccine for children ages 5 to 11. Pfizer said initial data from studies of two younger groups – those age 2 to younger than 5, then those age 6 months to younger than 2 – “are expected as soon as fourth quarter 2021 or early first quarter 2022.”

These additional doses are expected to be delivered by April 30, 2022, and bring the total number of Pfizer doses purchased to 600 million. This is the total number of doses the United States is able to acquire under the agreement with Pfizer in July 2020.

In a separate agreement, Pfizer agreed to provide 1 billion doses to the US government that would go to low- and lower-middle-income countries.

Deliveries of those doses began in August 2021; all the doses are expected to be delivered by the end of September 2022.

Vaccine advisers to the US Food and Drug Administration voted 17-0 with one abstention Tuesday to recommend emergency use authorization of Pfizer’s Covid-19 vaccine in children 5 to 11.

Members of the FDA’s Vaccines and Related Biological Products Advisory Committee agreed that the benefits of vaccinating younger children appeared to outweigh the risks, but some members appeared troubled about voting to vaccinate a large population of younger children based on studies of a few thousand. 

“It is reassuring to me that we are giving a lower dose,” said Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia. Pfizer has cut its vaccine to one-third of the adult dose for the children under 12. 

But Dr. Amanda Cohn of the US Centers for Disease Control and Prevention reminded the committee that children have died of Covid-19. According to CDC, more than 700 children 18 and under have died of Covid-19. “We don’t want children dying of Covid,” she said. “And we don’t want children in the ICU.”

The FDA had said that, under most of the scenarios it projected, the benefits of vaccinating younger children would outweigh any risks and Pfizer said clinical trials showed the vaccine was more than 90% effective in preventing symptomatic infection in children.  

What happens next: The FDA will take the committee’s vote into consideration and then make the final decision about whether to authorize it.  Then, the US Centers for Disease Control and Prevention’s independent advisory committee meets Nov. 2 and 3, and will vote on whether to recommend the vaccine for this age group.

Finally, CDC Director Dr. Rochelle Walensky will decide whether to accept or modify the committee’s recommendation.

Once Walensky signs off, younger children could start getting Covid-19 shots immediately.

The US federal government has a plan in place for delivering the smaller-sized vaccines to pediatricians’ offices, pharmacies and other venues across the country.