The United States government and Pfizer apparently reached an agreement to delay the U.S. regulatory decision on the company’s COVID-19 vaccine for children as young as 6 months old, Pfizer’s CEO said on March 13.

“We all agreed it’s better if we wait for the three doses to come out,” CEO Albert Bourla said on CBS’ “Face the Nation.”

Pfizer and its partner BioNTech have been testing their vaccine on children aged 6 months to 4 years and said in late 2021 that they going to expand the dosage to three doses because the two-dose regimen didn’t provide a sufficient immune response in some children.

Before a clinical trial could be completed, the Food and Drug Administration (FDA) asked Pfizer for data on the vaccine. The spike in COVID-19 cases and hospitalizations from the Omicron virus variant caused the regulators to consider emergency use authorization for the jab to the youngest population.

Officials were prepared to grant the expanded authorization in February, however just days before a scheduled vaccine advisory panel meeting, they announced they were postponing their decision.

“The data that we saw made us realize that we needed to see data from a third dose, as in the ongoing trial, in order to make a determination that we could proceed with doing an authorization,” Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, told reporters on a call. He said he hoped the move would “reassure” people that the FDA was “making sure that anything that we authorize has the safety and efficacy that people have come to expect from our regulatory review of medical products.”

Dr. Scott Gottlieb, a former FDA chief who sits on Pfizer’s board, said children in the trial were still getting infected with COVID-19.

When asked, Bourla said Sunday that FDA officials were “very keen” for the company to send the data over, but Pfizer executives were “a little bit reluctant to submit on two doses, because we felt that the three-dose [regimen] is what kids will need.”

Eventually, the parties reached an agreement, according to the Pfizer CEO.

“It’s one thing to have a vaccine out there, it’s another thing to have a clear picture for the parents that all scientists, that they all agree—CDC, FDA, the industry, academia—that this is the right thing to do for the kids,” Bourla said, adding that he believes three doses “will likely provide a very strong set of evidence where everybody will agree.”

Some experts have questioned the need for a vaccine in little kids at all, noting the waning effectiveness taking place in older kids. Kids aged 12 to 17 have been advised to get a third dose due to this waning of immunity. The possibility of side effects, and the fact that children are far less likely to suffer symptomatic or severe cases of COVID-19 when compared to older age groups.

Other experts remarked, “that the benefits of the vaccine offer some level of protection, even if insubstantial, against infection, and stronger protection against severe disease outweigh the risks and that kids should have that protection available to them.”

Bourla said that the data on how a three-dose regimen works for children as young as 6 months will likely be available in April, and that authorization could come in May, “if it works.”

“I’m sure, (regulators) will do their utmost to review them fast,” he said, “and we will be ready with manufacturing.”

In Other Breaking Vaccine News: Vaccine Tinnitus

In an article published for the March edition in the “Annals of Medicine and Surgery,” about 12,247 cases of COVID-19 post-vaccination tinnitus were reported until Sept. 14, 2021. Tinnitus is when one experiences ringing or other noises—that are not external sounds—in one or both ears, affecting between 15 and 20 percent of all people, says the Mayo Clinic.

“To the best of our knowledge, this is the first review evaluating any otologic manifestation following vaccine administration and aims to evaluate the potential pathophysiology, clinical approach, and treatment. Although the incidence is infrequent, there is a need to understand the precise mechanisms and treatment for vaccine-associated-tinnitus,” said the researchers.”

With this high number of cases, they argued that,

“there is an overwhelming need to discern the precise pathophysiology and clinical management” of vaccine-associated-tinnitus because “despite several cases of tinnitus being reported following SARS-CoV-2 vaccination, the precise pathophysiology is still not clear.”

The researchers, led by Syed Hassan Ahmed with the Dow University of Health Sciences, noted that “stress and anxiety following COVID-19 vaccination could also play a role. Whether vaccine-related anxiety, they said, plays a role in the cause of tinnitus should be evaluated.”

Ahmed and the other researchers believe the benefits of the COVID-19 vaccines outweigh the side effects.

Dr. Gregory Poland, the head of the Mayo Clinic’s Vaccine Research Group in Minnesota, told Medpage Today that he developed tinnitus soon after receiving his first COVID-19 vaccine shot.

“It was like someone suddenly blew a dog whistle in my ear,” Poland told MedPage Today, adding that the tinnitus symptoms have been life-altering. “It has been pretty much unrelenting.” Poland continued to say that he “can only begin to estimate the number of times I just want to scream because I can’t get rid of the noise or how many hours of sleep I’ve lost.” The noise that he hears can be “particularly loud at night when there are no masking sounds.”

Despite the tinnitus, Poland—who said he’s received numerous emails about individuals who developed tinnitus after getting the COVID-19 shot—told the outlet that he is still a proponent of the COVID-19 vaccine and received a booster dose.

The tinnitus, he added, occurs in both ears, noting that it is worse in the left than in the right ear.

“What has been heartbreaking about this, as a seasoned physician, are the emails I get from people that, this has affected their life so badly, they have told me they are going to take their own life,” Poland said.

A spokesperson for the Centers for Disease Control and Prevention (CDC), which runs VAERS, (Vaccine Adverse Event Reporting System) noted that “tinnitus is a common condition, heterogeneous in nature, and has many causes and risk factors,” adding that “hundreds of millions of people have received mRNA COVID-19 vaccination under the most intensive monitoring in U.S. history.”