WASHINGTON — A COVID-19 vaccine for young children will be delayed by at least two months as Pfizer and BioNTech gather more information on a three-dose regimen.
The disappointing news for many parents came after the Biden administration earlier had announced it was preparing to get the vaccines out to states as soon as it could following federal approval.
The pharmaceutical companies and the Food and Drug Administration released separate statements Friday saying a review of the vaccine for children under 5 years old will likely not take place until early April.
“Based on the agency’s preliminary assessment, and to allow more time to evaluate additional data, we believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization,” the FDA said in a statement.
The FDA said it would postpone the Vaccines and Related Biological Products Advisory Committee meeting scheduled for Tuesday to “give the agency time to consider the additional data, allowing for a transparent public discussion as part of our usual scientific and regulatory processes for COVID-19 vaccines.”
Pfizer and BioNTech began submitting data to the FDA on a two-dose regimen for children under 5 earlier this month at the request of the agency.
Pfizer Chairman and Chief Executive Officer Albert Bourla said at the time the company would submit data on a two-dose regimen while it continued researching a three-dose regimen.
“Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants,” he said on Feb. 1.
The Biden administration immediately began getting ready for approval of the emergency use authorization request. White House Coronavirus Response Coordinator Jeffrey Zients said the next day the federal government was preparing to ship the vaccine to states as soon as it was approved.
“Following FDA authorization, we would immediately begin packing and shipping doses to states and health care providers,” Zients said, noting the federal government had already “secured ample doses and the necessary needles and supplies” designed for this age group.
The White House was also preparing to work with local and state health officials as well as pediatricians to distribute information about the vaccine, including to hesitant parents.
That process now won’t get underway until at least April, as Pfizer and BioNTech gather more data on what will likely be a three-shot vaccine.
“Given that the study is advancing at a rapid pace, the companies will wait for the three-dose data as Pfizer and BioNTech continue to believe it may provide a higher level of protection in this age group,” the companies said in a statement. “The companies expect to have three-dose protection data available in early April.”
WASHINGTON — Pfizer and BioNTech on Tuesday asked the federal government to begin the approval process for a two-dose COVID-19 vaccine for children under 5.
The companies said in a joint statement they began the rolling submission process for an emergency use authorization at the request of the Food and Drug Administration “in response to the urgent public health need in this population.”
While the approval process is underway for the two-dose regimen, the company will continue researching a third dose that would likely be given at least eight weeks after a child receives the second dose.
Pfizer Chairman and Chief Executive Officer Albert Bourla said in the statement that increasing infections and hospitalizations of young children led the two companies to begin the approval process.
“As hospitalizations of children under 5 due to COVID-19 have soared, our mutual goal with the FDA is to prepare for future variant surges and provide parents with an option to help protect their children from this virus,” Bourla said.
“Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants.”
Bourla said that if the FDA authorizes the two doses, that would allow parents to begin vaccinating their young children while waiting on approval of a third dose.
The submission announcement on Tuesday comes sooner than previously expected.
In mid-December, Pfizer and BioNTech announced they were modifying their trial to include a third dose of the vaccine for children between 2 and 4 years old after the two-dose approach didn’t lead to the type of immune response researchers sought. The trial did, however, produce the levels desired in children between six months and 2 years old.
The company said at the time that if the three-dose trial was successful, it would likely submit its emergency use request to the federal government in the first half of 2022.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, then said last week that parents needed to be patient in waiting for approval of the vaccine for younger children.
“I don’t think we can predict when we will see an [emergency use authorization] with that because the company is still putting the data before the FDA,” Fauci said during a White House briefing on the pandemic.
A poll released Tuesday by the Kaiser Family Foundation indicated about 31 percent of parents would get their small children vaccinated immediately.
Another 29 percent said they would wait and see while 12 percent said only if required and 26 percent of respondents said they definitely would not give their young child the vaccine.
Nursing home workers are passing on their chance at early access to the COVID-19 vaccine, officials say, blowing a crosswind against a scarce supply of doses and a pandemic in a tailspin.
“I think in this case, [DeWine] is on target,” said Pete Van Runkle, executive director of an industry association representing Ohio’s long term care facilities.
“I talk to a lot of members on a regular basis. They are reporting a pretty low uptake among staff.”
Patrick Schwartz
Patrick Schwartz, a spokesman for Leading Age Ohio, an elder advocacy group, said he’s hearing mixed reports of some providers finding that 90% of staff chose to take the vaccine while others are “well below 50%.”
He attributed the shortfalls to misinformation and fear surrounding the potential for an adverse reaction to the vaccine.
“Many staff are simply ‘not yet ready,’ which will hopefully change as they see more and more colleagues vaccinated without side effects and confidence continues to build,” he said.
“By contrast, an overwhelming majority of residents seem willing to accept the vaccine, with many coming from the generation that saw polio and other deadly diseases wiped out by life-saving vaccines.”
The local Service Employees International Union surveyed its members on the issue, it said in a statement Monday.
The responses, according to SEIU 1199 President Becky Williams, indicate a trust problem between an exhausted, underpaid, underappreciated, and in many cases already-infected staff and health authorities.
She said this is a “substantial issue” that’s bigger than just the union and requires outreach and education from the state.
“Workers commented that the vaccine appeared rushed and unproven without enough data to show that it would be effective,” she said.
“Some workers are also concerned that the vaccine could cause fertility issues among women who may want to have a child. There are trust issues among frontline health care workers — some of which preceded the pandemic. These trust issues continue after so many nursing home workers have been on the frontlines of the pandemic without hazard pay and support such as needed personal protective equipment.”
Several news outlets have debunkedthisnotion of ‘fertility issues’ related to the vaccine. A quick scroll through the right Facebook group can deluge visitors with this and similar pieces of misinformation relating to the vaccine.
The Ohio Capital Journal called 13 state long-term care facilities Monday, who have each reported at least 100 COVID-19 cases among their residents, to discuss vaccination among their staffs. No administrators agreed to an interview.
Two vaccines (one from Moderna and one jointly from Pfizer and BioNTech) are currently approved for emergency use against COVID-19. They are both two-dose vaccines, taken several weeks apart.
Company data reviewed by the Food and Drug Administration shows both vaccines are about 95% effective preventing symptoms of COVID-19. While side effects (sometimes more intense than a standard flu vaccine) have been reported with both products, none of the vaccine trials have reported any serious safety concerns, according to information from Johns Hopkins University.
Before coming to market, both vaccines underwent large scale clinical trials over the course of months. They are now under review via continuous monitoring for problems and side effects from the FDA and the CDC.
The vaccine hesitancy comes as COVID-19 has infected 727,000 Ohioans, put about 39,000 in the hospital, and killed at least 9,143 since March.
At least 4,856 of those deaths occurred among residents of Ohio’s long-term care facilities.
There are several theories as to why nursing home workers would rebuff a vaccine dose, according to Tory Hogan, an Ohio State University professor who researches nursing homes and infection control.
She said some probably just don’t trust health authority; some have “been in the trenches” of the pandemic for a year now, prompting them to shrug off the unknown risk of vaccine for the better-known risk of infection; some probably just don’t want to be the guinea pigs.
“There has been so much misinformation about everything in this process,” she said.
Wood County Health Commissioner Ben Robison said he’s detected some vaccine hesitancy and refusal across all industries. However, some who deny at first are likely to come around.
“Anecdotally, we’ve heard among some of the populations we’re reaching with our vaccine, some have initially said no and then later said yes,” he said.
Some employers, especially in the health care industry, mandate the flu vaccine and other immunization. However, Van Runkle said the industry is already dealing with a widespread staffing shortage, only worsened by the pandemic.
He said most of Ohio’s nursing homes do not even mandate the flu vaccine. Mandating a COVID-19 vaccine would worsen staffing problems.
“We don’t need another reason for people not to work in our facilities,” he said.
A vaccine mandate would backfire
Hogan agreed that a vaccine mandate would backfire, and Williams, from SEIU, said education and outreach should drive universal vaccination.
The Ohio Department of Health has shipped 341,100 Moderna first-doses, as well as 9,750 Pfizer first-doses plus another 9,750 Pfizer second-doses, according to ODH spokeswoman Melanie Amato. Only about 162,942 Ohioans have started the vaccination process, which is prioritizing health care workers, first responders and nursing home staff and residents.
“We do not have visibility to how many staff members at a facility decline to be vaccinated,” said CVS Health Spokesman Charlie Rice-Minoso.
“While we aren’t provided with full staff rosters, based on feedback from our teams in the field we’re seeing more vaccine hesitancy among staff when compared with residents.”
Walgreens, another company administering the vaccines, did not respond to inquiries.
Looking at the bigger picture, Hogan said governments from the federal to local level need to do a better job understanding why some are declining vaccination. Similarly, she said they need to emphasize, as they did during the polio years, that vaccination is the patriotic thing for Americans to do.
“It takes consistently pushing the right message, the correct and accurate information,” she said. “That takes money, a federal response, all levels. We’re struggling with that a lot.”
