White House coronavirus adviser Dr. Anthony Fauci said children younger than 4 years old likely will receive three doses of the Pfizer COVID-19 when it’s approved after clinical trials showed two doses were ineffective.
“It looks like it will be a three-dose regimen,” he said at a White House news conference Wednesday.
Fauci said he could not predict when it will be approved, noting he he can’t speak for the Food and Drug Administration. He previously acknowledged that Pfizer found in its clinical trials in children ages 2 to 4 that two shots did not induce an adequate immune response.
“We need to be patient,” he said. “That’s why the system works. The FDA is very scrupulous in their ability and in their effort to make sure that, before something gets approved for any age, and especially with children … that they will be safe, and that they will be effective.”
However, members of FDA and CDC advisory panels have expressed concern that safety data for children regarding Pfizer’s COVID vaccine is lacking while children have a nearly 100% survival rate from infection. Some members of an FDA panel said they reluctantly approved the shots for children 5-11 because they wanted high-risk children to have access. Panel member Dr. Eric Rubin, editor-in-chief of the New England Journal of Medicine, said: “”We’re never going to learn about how safe the vaccine is unless we start giving it. That’s just the way it goes.”
Further, the move to vaccinate young children is moving ahead despite acknowledgment the vaccines don’t prevent infection or transmission of the virus, and consensus that the current omicron variant presents with mild symptoms.
Meanwhile, the World Health Organization’s chief scientist said last week that healthy children and adolescents don’t need COVID-19 vaccine booster doses.
“There is no evidence right now that healthy children or healthy adolescents need boosters. No evidence at all,” said Soumya Swaminathan at a news briefing Tuesday.
Last month, Dr. Robert Malone, the leader inventor of the mRNA technology behind the Pfizer and Moderna vaccines, issued a video statement explaining why more than 15,000 physicians and medical scientists around the world have signed a declaration that healthy children should not be vaccinated for COVID-19.
Malone said there is “no benefit for your children or your family to be vaccinating your children against the small risks of the virus, given the known health risks of the vaccine that as a parent, you and your children may have to live with for the rest of their lives.”
Pfizer CEO Albert Bourla acknowledged earlier this month that two doses of his vaccine “offer very limited protection, if any” against omicron. And he said the mRNA vaccines “don’t have the safety profile that we hoped we can achieve with this technology.” Pfizer is working on a new vaccine to target omicron that he hopes will be ready by March.
Preliminary results released this week of a landmark Israeli study conducted over the past month found that a fourth Pfizer booster shot is only partially effective in protecting against the omicron variant. A German government report found more than 95% of reported cases of the omicron COVID-19 variant in the country were in vaccinated individuals.
Earlier this month, the European Union’s top health agency warned that getting boosted every four months could harm the immune system’s ability to fight off the disease. The European Medicines Agency advised countries instead to mirror the seasonal influenza vaccination strategy tied to the onset of the cold season. And the WHO said in a statement last week that a vaccination strategy based on repeated booster doses of the original COVID-19 vaccines is unlikely to be appropriate or sustainable.
‘This signals the end of the pandemic’
CDC Director Dr. Rochelle Walensky told reporters earlier this month she saw no indication that omicron was causing more severe illness in children. And research indicated that the delta variant did not make kids sicker compared with previous variants.
Real-world data from the U.S., U.K. and South Africa has indicated omicron causes less severe illness in adults.
Last week, after the models upon which he based his policies proved to be “wildly incorrect,” British Prime Minister Boris Johnson announced the lifting of COVID-19 vaccine passports, mask mandates and work-from-home guidance in England.
And countering the pessimism of Fauci, former U.S. Food and Drug Administration commissioner Scott Gottlieb said there is hope the coronavirus pandemic will be over soon.
Average daily COVID-19 cases had fallen at least 10% in the previous week in the United States, and Gottlieb believes that if the virus continues on its present course, it likely will become endemic soon.
“I think the base case is that this signals the end of the pandemic phase of this virus,” Gottlieb told CNBC’s “Squawk Box.”