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The US Food and Drug Administration would consider lowering the age range on its emergency use authorizations for booster shots for coronavirus vaccines once more safety data comes in, officials told reporters Wednesday.
The FDA authorized booster doses of both Moderna and Johnson & Johnson vaccines, but limited the EUA for Moderna’s vaccine to people 65 and older or those who are at least 18 and at high risk of severe Covid-19 or have frequent institutional or occupational exposure to the virus.
Dr. Peter Marks, director of the FDA’s vaccine arm, the Center for Biologics Evaluation and Research, said the ability to use any authorized vaccine as a booster will simplify matters for people.
“Being able to interchange these vaccines is a good thing. It’s like what we do with flu vaccines. Most people don’t know what brand flu vaccine they received,” Marks told reporters in a telephone briefing.
Marks said the FDA would consider lowering the age ranges for booster shots as more safety data comes in.
“We want to make sure that if we deploy the boosters in all of the age ranges, that we truly are making a benefit outweigh any risk,” Marks said. “We will not hesitate to drop this age range as we see this benefit outweigh the risk, and because of the EUA authority that we have, we can do that in a relatively quick amount of time.”
Marks said one concern was the risk of an inflammatory heart condition in young men known as myocarditis. The risk is a little higher in men who got second doses of Pfizer and Moderna vaccines. But booster doses do not seem to be associated with a higher risk of this condition, he said.
“It may be that the additional time between doses…helped reduce that risk of myocarditis,” he said.
NBA legend Kareem Abdul-Jabbar today sharply criticized seven-time All-Star Kyrie Irving for so far refusing to get a vaccine, saying he was letting down his teammates and setting a poor example for his fans.
“I think people who are followed, who have a huge platform like that, have a responsibility greater than just the average citizen,” said Abdul-Jabbar, speaking on CNN. “Young kids, especially, look up to Kyrie and are trying to model their lives after his and become great athletes.”
Irving revealed last Wednesday that he is unvaccinated a day after his team said he would not be allowed to play or practice this season until he met eligibility requirements.
The NBA had warned the Brooklyn Nets, as well as the New York Knicks and Golden State Warriors, that new Covid-19 policies set by local governments will prohibit any unvaccinated player from playing in home games in New York City and San Francisco.
Speaking on Monday, the sport’s commissioner Adam Silver, told reporters he understood the vaccine mandate and urged Irving to reassess his decision.
“I think it’s perfectly appropriate that New York and other cities have passed laws that require people who both work and visit arenas to be vaccinated,” Silver said.
The US Food and Drug Administration authorized booster doses of both Covid-19 vaccines made by Moderna and Johnson & Johnson Wednesday.
“We welcome the FDA’s decision to authorize emergency use of our COVID-19 vaccine as a booster,” said Paul Stoffels, M.D., vice chair of the executive committee and chief scientific officer of Johnson & Johnson.
Stoffels continued:
Meanwhile, Mathai Mammen, who is the global head of Janssen research and development with Johnson & Johnson, said the authorization is “yet another positive step toward the goal of curbing the COVID-19 pandemic.”
“It is now even clearer that Johnson & Johnson’s vaccine booster can play an important role in maintaining protection against COVID-19. We look forward to sharing our robust safety, efficacy and immunogenicity data in support of a booster dose with other regulatory bodies and advisory groups around the world to address the continued threat of COVID-19,” Mammen added.
The US Food and Drug Administration on Wednesday authorized booster doses of both Covid-19 vaccines made by Moderna and Johnson & Johnson.
Here’s what happens next: The US Centers for Disease Control and Prevention’s vaccine advisers, the Advisory Committee on Immunization Practices, meets tomorrow to decide on whether to recommend the FDA’s authorization for the Americans people.
Earlier today, the CDC published a final agenda for the vaccine advisory committee meeting. The panel will be discussing booster doses of Moderna and J&J vaccines, and mixing and matching of boosters. A vote is scheduled between 4:20 p.m. ET and 5 p.m. ET.
After that, the CDC director will decide whether to sign off on the advisers’ guidance.
The US Food and Drug Administration authorized booster doses of both Covid-19 vaccines made by Moderna and Johnson & Johnson Wednesday and also said any of the three authorized vaccines could be used as a booster in a “mix and match” approach.
The FDA gave emergency use authorization for boosters of Moderna’s vaccine for people fully vaccinated at least six months ago who are also at least 65, or who are at least 18 and who are high risk of severe Covid-19 or have frequent institutional or occupational exposure to Covid-19.
“The use of each of the available COVID-19 vaccines as a heterologous (or ‘mix and match’) booster dose in eligible individuals following completion of primary vaccination with a different available COVID-19 vaccine,” the FDA said.
“To clarify that a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine may be administered at least 6 months after completion of the primary series to individuals 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2,” it added.
The US Centers for Disease Control and Prevention’s vaccine advisers, the Advisory Committee on Immunization Practices, will meet tomorrow to decide on whether to recommend the FDA’s authorization for the Americans people, and then the CDC director will decide whether to sign off on ACIP’s guidance.
New York City Mayor Bill de Blasio said during a news conference Wednesday that he does not anticipate any legal issues with the latest vaccine mandate extending to all city workers.
“I don’t anticipate legal issues. I’ve had this conversation with our corporation counsel…many times. We have seen, uniformly, courts agree and support vaccine mandates by governments, certainly by this government,” de Blasio said.
When asked about potential staffing shortages, particularly among NYPD and FDNY members who may refuse to get vaccinated, the mayor said they “obviously have contingencies in place for any gaps that we experience” and that the city’s “uniformed agency leadership feel very strongly that they will be able to handle any scenario.”
De Blasio continued by saying that he believes many unvaccinated city workers will decide to get vaccinated due to needing a paycheck.
The Biden administration “fully supports” the New York City vaccination mandate for all city workers, White House Vaccinations Coordinator Dr. Bechara Choucair said during a press conference Wednesday.
“Today’s announcement is another important step to help get New York and the country protected, and sets an example for our country. So, we at the Biden administration fully support this action. The fact is, vaccine requirements are working,” Choucair said.
Choucair said that vaccine mandates are also good for the economy and for the labor market, particularly in getting more people back to work, “as people feel safer going back to the workplace and face fewer disruptions, including childcare.”
There’s no evidence a new sublineage of the Delta variant is having any significant effect in the United States, US Centers for Disease Control and Prevention director Dr. Rochelle Walensky said Wednesday.
While the AY 4.2 coronavirus subvariant has been identified in the United States, it’s not growing in frequency or causing clusters, Walensky told a White House Covid-19 briefing.
“At this time, there is no evidence that the sublineage AY 4.2 impacts the effectiveness of our current vaccines or therapeutics,” she said.
“CDC is continuing to track lineages and sublineages of Delta, and all other variants,” Walensky said. “We particularly monitor for sublineages that could impact therapeutics, such as monoclonal antibodies and vaccines.”
White House Covid-19 Response Coordinator Jeff Zients outlined the administration’s plans to deploy Covid-19 vaccines for children ages 5 to 11, contingent on approval by the Food and Drug Administration and Centers for Disease Control and Prevention, including a number of operations geared specifically towards vaccinating children.
The FDA has already scheduled a meeting of its independent advisers, the Vaccines and Related Biological Products Advisory Committee or VRBPAC, for Oct. 26 to discuss the data. VRBPAC, which includes several pediatricians, will listen to what both Pfizer and the FDA have to say about what studies show and will also hear public input.
The FDA could act quickly after the VRBPAC meeting – in hours, even – and then vaccine advisers to the US Centers for Disease Control and Prevention will meet. The Advisory Committee on Immunization Practices is made up of different experts.
ACIP has scheduled a meeting for Tuesday and Wednesday Nov. 2-3 to discuss the question. The CDC Director, Dr. Rochelle Walensky, will then decide whether kids should get the vaccine based on this input.
It could take five weeks after the first dose for kids’ to have full immunity:
Just as with adults, Pfizer is testing and proposing a two-dose series for kids. So that would mean two doses of vaccine given three weeks apart. And as with adults, immunity isn’t immediate, even after the second dose. People have been considered fully vaccinated two weeks after the second dose and the same will go for kids.
So at the very earliest, children would be advised to continue taking precautions for five weeks after they get the first dose of vaccine. That means wearing masks, keeping a physical distance from others and avoiding crowded indoor spaces when possible.
As for boosters, it’s far too soon to ask about them. It took several months of gathering real-world data before Pfizer asked FDA to authorize boosters in adults.
People who haven’t been vaccinated against Covid-19 are more than 18 times more likely to end up in the hospital with Covid-19 than vaccinated people, US Centers for Disease Control and Prevention Director Dr. Rochelle Walensky said Wednesday.
A new CDC data tool shows the value of vaccinating people against the virus, Walensky told a White House briefing. She showed some graphs generated by the new tool and said unvaccinated people were more than 11 times more likely to die.
“For the week ending August 28, 2021, the hospitalization rate in fully vaccinated people was 4.5 per 100,000, shown by the green line, while the hospitalization rate in unvaccinated people was 83.6 per 100,000, shown by the blue line — an 18.5 fold increase in hospitalizations for those who are unvaccinated,” she said.
But Walensky said the number of cases and deaths was improving very slightly. “As of yesterday, the seven day daily average of cases was about 75,500 cases per day, which represents a decrease of about 16% over the prior week. The seven day average of hospital admissions was about 6,000 per day — also, a decrease of about 11% from the prior week. And the seven day average of daily deaths were about, 1,200 per day, a decrease of about 3% from the previous week.”
Getting most children vaccinated against Covid-19 will “play a major role” in slowing the spread of disease and pushing the nation closer to herd immunity, Dr. Anthony Fauci said Wednesday.
About 28 million children ages 5 to 11 will soon become eligible to get vaccinated against Covid-19 if the US Food and Drug Administration authorizes shots for this age group and if the US Centers for Disease Control and Prevention recommends it.
“If we can get the overwhelming majority of those 28 million children vaccinated, I think that would play a major role in diminishing the spread of infection in the community,” said Fauci, who is chief medical adviser to President Biden and director of the National Institute of Allergy and Infectious Diseases.
“That’s one of the reasons why we want to do as best as we can to get those children from 5 to 11 vaccinated.”
The White House plans to launch a nationwide public education campaign for parents of children ages 5 to 11 about the safety and effectiveness of coronavirus vaccines —including sending letters to parents and hosting forums, US Surgeon General Dr. Vivek Murthy said Wednesday.
“We’re preparing a national public education campaign that will meet parents where they are with information about the vaccines,” Murthy told a White House briefing.
The campaign is part of a larger program preparing for the anticipated authorization of a coronavirus vaccine for young children by the US Food and Drug Administration and sign off by the US Centers for Disease Control and Prevention.
“We will provide faith leaders with materials and toolkits that they can distribute to their congregations. We will create forums for parents to ask questions to health experts,” Murthy said. “With all of this, we will make sure that we are reaching parents in their language and through the people they trust.”
Murthy mentioned that he is the parent of a 5-year-old. “One of the barriers and challenges we will face to getting vaccines to children is a similar barrier we face with adults, which is that there’s a profound amount of misinformation that is circulating about vaccines. And that’s why we’re making sure that it’s trusted messengers with scientific credibility who go out there and talk about these vaccines,” Murthy said.
White House Covid-19 Response Coordinator Jeff Zients outlined the administration’s plans to deploy Covid-19 vaccines for children ages 5 to 11, contingent on approval by the Food and Drug Administration and Centers for Disease Control and Prevention, including a number of operations geared specifically towards vaccinating children.
“Together we’re completing the operational planning to ensure vaccinations for kids ages 5 through 11 are available, easy, and convenient,” Zients said, boasting the administration has been working closely “with governors, pediatricians, pharmacies, community health centers, rural health centers and other vaccine providers to prepare for this moment.”
On vaccine supply, Zients said the administration has already “secured vaccine supply to vaccinate every child ages 5 through 11, and as soon as the vaccine is authorized by the FDA, we will begin shipping millions of doses nationwide.” The administration has already partnered with vaccine manufacturer Pfizer to modify vaccine packaging “to modify the packaging of the pediatric doses to make it easier for pediatricians, family doctors, and other providers to provide vaccines to children.”
“These vaccine doses will be shipped with all the supplies needed to vaccinate kids, including smaller needles,” Zients added.
To actually get shots in arms, Zients has “already enrolled more than 25,000, pediatricians, and doctors and other primary care providers to administer vaccines, and we’re working with states and localities to enroll more,” while setting up vaccination sites in school districts and children’s hospitals, “including on nights and weekends,” to ensure vaccinating kids “is even more convenient.”
Ensemble forecasts from the US Centers for Disease Control and Prevention published Wednesday project that new Covid-19 deaths and hospitalizations will continue to decrease over the next four weeks for the fourth and sixth consecutive week, respectively.
The latest forecast predicts that there will be a total of 748,000 to 769,000 Covid-19 deaths reported by Nov. 13.
The previous forecast, published Oct. 13, predicted up to 762,000 Covid-19 deaths reported by Nov. 6.
According to data from Johns Hopkins University, there have been 728,313 Covid-19 deaths in the United States.
The CDC forecast predicts that there will be 1,600 to 8,700 new confirmed Covid-19 hospital admissions likely reported on Nov. 12.
As of Oct. 19, there were 57,424 people hospitalized with Covid-19, according to data from US Health and Human Services.
The case forecasts did not predict an increase or decrease in cases.
New York City Mayor Bill de Blasio said extending the city’s vaccine mandate to all municipal workers will help protect New Yorkers against Covid-19.
“My job is to keep New Yorkers safe, and the vaccine is what does it,” de Blasio said during an interview on CNN.
All city workers will need to have at least one vaccine dose by 5 p.m. ET on Oct. 29. They will receive an extra $500 for getting vaccinated at a city-run site by that date.
De Blasio said about 46,000 city employees are not yet vaccinated.
If they choose not to get vaccinated, the workers will go on unpaid leave, the mayor said.
De Blasio added that 96% of both education and healthcare workers are vaccinated. Both sectors have been under vaccine mandates since late September.
“The mandates work. … Every mayor in America, every governor, every CEO of a company should do the same thing so we can end the Covid era,” he said.
Watch:
The White House Covid-19 response team and federal public health officials is holding a news briefing to provide updates on their coronavirus response effort.
Earlier Wednesday, the White House unveiled its plans to roll out Covid-19 vaccines for children ages 5 to 11, pending US Food and Drug Administration authorization.
The Biden administration has secured enough vaccine supply to vaccinate the 28 million children ages 5 to 11 who would become eligible for vaccination if the vaccine is authorized for that age group and will help equip more than 25,000 pediatric and primary care offices, hundreds of community health centers and rural health clinics as well as tens of thousands of pharmacies to administer the shots, according to the White House.
Speakers attending the briefing include:
As the White House on Wednesday unveiled its plans to roll out vaccines for children ages 5 to 11, US Surgeon General Dr. Vivek Murthy said on NBC’s Today that US health officials want to be prepared for children to be able to get vaccines as soon as they can.
These preparations include ensuring there is enough supply for every child in the 5- to 11-year-old age range, making sure there are tens of thousands of locations where people can get the vaccines and making sure that parents have answers to their questions and accurate scientific information that can be used in decision making, Murthy said.
He said that ensuring that parents had the answers to their questions was “really important,” and so they have been working hard with doctors, nurses, teachers, parents and other community organizations to make sure that people can get the answers to their questions from trusted sources.
The Pfizer/BioNTech vaccine is 93% effective in preventing hospitalization due to Covid-19 among children ages 12 to 18, according to a study by the US Centers for Disease Control and Prevention. Vaccine effectiveness differed only slightly within that age group, with 91% effectiveness for children age 12 to 15 and 94% effectiveness for those age 16 to 18.
The study included 464 patients — 179 hospitalized with Covid-19 and 285 hospitalized for other reasons — across 19 pediatric hospitals in 16 states between June and September 2021, a time period when the Delta variant was dominant. The majority of patients had at least one underlying condition (72%) and attended in-person school (68%), and most patients were from southern states, as Covid-19 transmission was high in that region during this timeframe.
Patients were considered fully vaccinated against Covid-19 if they had received their second dose of the Pfizer/BioNTech vaccine at least 14 days before illness onset. Those partially vaccinated — with only one dose or with less than 14 days since the second dose — were excluded from the analysis.
Among the 179 patients hospitalized with Covid-19 in the study, all of the critically ill patients were unvaccinated. About 43% (77 patients) were admitted to an intensive care unit, 29 received life support during hospitalization and two died.
Since August 2020, more than 65,000 children have been hospitalized with Covid-19 and nearly 700 have died, according to CDC data.
The US government likely will soon recommend booster shots to people as young as 40 who received either Moderna or Pfizer’s Covid-19 vaccine, according to a source familiar with the plan.
Last month, the US Food and Drug Administration authorized booster shots for people age 65 and older who received their second shot of Pfizer’s vaccine at least six months ago. For younger people, the booster is authorized only for certain groups, such as those with certain health conditions or those working in jobs that put them at high risk for contracting Covid-19.
Last week, a panel of FDA advisers recommended that Moderna boosters be given with the same rules. However, boosters for Moderna have yet to be granted authorization by the FDA.
The source said there is “growing concern within the FDA” that US data is beginning to show hospitalizations among people under age 65 who have been fully vaccinated.
If the FDA backs lowering the age for boosters, the plan would then go to the US Centers for Disease Control and Prevention for its sign off. Vaccine advisers to that agency are meeting Thursday to discuss Covid-19 booster shots.
Israel, where nearly all vaccinations have been with Pfizer, started offering boosters in August to everyone more than six months past their second shot, regardless of age.
Israeli researchers told the FDA advisers last week that the boosters have reduced the rate of severe disease in people over age 40.
At that meeting, a senior FDA official said the Israeli data “seems compelling.”
Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, mentioned that newly emerging data in the US “makes us realize that we’re concerned that what was seen in Israel could be seen here.”
“We don’t want to have a wave of severe Covid-19 before we deploy boosters,” he added.
Several members of the advisory committee expressed support for lowering the age recommendation.
“In general, I wasn’t a fan of reducing the cutoff to a lower age, because I think this severe disease isn’t terribly great in that population, but hearing all these arguments I would support that now more,” said Dr. Stanley Perlman, a professor of pediatrics at the University of Iowa.
The advisers voiced concern about giving boosters to younger people, since Pfizer and Moderna’s vaccine have been associated with myocarditis, or inflammation of the heart muscle, in male adolescents and young adults.
Last week, the FDA vaccine advisers recommended that people of all ages who received a Johnson & Johnson vaccine get a booster two months after their original shot. Boosters for this vaccine are also awaiting authorization by the FDA.
The White House unveiled its plans to roll out Covid-19 vaccines for children ages 5 to 11, pending US Food and Drug Administration authorization
The Biden administration has secured enough vaccine supply to vaccinate the 28 million children ages 5 to 11 who would become eligible for vaccination if the vaccine is authorized for that age group and will help equip more than 25,000 pediatric and primary care offices, hundreds of community health centers and rural health clinics as well as tens of thousands of pharmacies to administer the shots, according to the White House.
Administration officials will provide more details on the rollout during an 8:45 a.m. ET briefing, an official familiar with the plans said.
The administration is also launching a partnership with the Children’s Hospital Association “to work with over 100 children’s hospital systems across the country to set up vaccination sites in November and through the end of the calendar year,” the White House announced.
The administration also plans to help make vaccination available at school and other “community-based sites” with help from Federal Emergency Management Agency funding.
The Department of Health and Human Services will also carry out a national public education campaign “to reach parents and guardians with accurate and culturally responsive information about the vaccine and the risks that COVID-19 poses to children.”
Vaccine advisers to the FDA are scheduled to meet next week to consider Pfizer’s request to authorize its vaccine to children ages 5 to 11.
