When faced with a variant like Omicron, Pfizer CEO Albert Bourla said on CBS’ “Face the Nation” on Sunday that the vaccine maker plans to submit data on a fourth dose of its COVID-19 vaccine to the US Food and Drug Administration because protection after three doses is “not that good against infections” and “doesn’t last very long,” and the vaccine will be required to keep hospitalizations and mild infections under control.
The business wants to submit data on a fourth dose to the FDA and is developing a vaccine that protects against all COVID variations for at least a year.
“I think we’re going to submit to the FDA a proposal,” Bourla said in an appearance on “Squawk Box.”
“There are so many trials that are going on right now, and a lot of them we’ll start reading by the He added, “By the end of the month.”
According to CBS, Bourla believes Americans will need to get a COVID booster every fall, much like they do with the flu vaccine.
Anyone 12 and older who had a second dosage at least five months previous to requesting the third dose is currently eligible for a third dose of Pfizer’s vaccine.
Bourla was already informing media outlets that the company’s long-term strategy was to have yearly vaccine boosters, as The Defender reported on Feb. 26, 2021, just two months after the FDA granted Emergency Use Authorization for the Pfizer-BioNTech vaccine.
According to WRCBtv, a CBS subsidiary, this will result in even more vaccination sales – and money.
“Every year, you need to go to get your flu vaccine,” Bourla said during an interview with NBC News. “It’s going to be the same with COVID. In a year, you will have to go and get your annual shot for COVID to be protected.”
Bourla informed analysts, huge banks, and investors during a February 2021 conference call that the company might make significant profits by charging higher fees and instituting routine booster treatments for emerging virus types.
Pfizer CFO Frank D’Amelio indicated at the Barclays Global Health Conference in March 2021 that he didn’t see this as a one-time event, but rather “as something that’s going to persist for the foreseeable future.“
Pfizer had already begun testing a third vaccine dose to address variations, called for annual boosts, and warned investors to expect a revenue stream similar to flu vaccines at the time.
At the time, the FDA stated that it was willing to approve booster injections based on modest clinical trials and data on vaccine effectiveness.
Pfizer estimates that its vaccine will generate $32 billion in revenue in 2022, down 13% from 2021.
Hospitalizations and deaths in the UK “remain persistently high and overwhelmingly occur in vaccinated persons,” according to data released on Substack by Alex Berenson, a former New York Times reporter.
90 percent of the 1,000 Britons who died of COVID each week were vaccinated last month. During the four weeks ended Feb. 27, 397 unvaccinated people died of COVID in the United Kingdom, compared to 3,512 vaccinated people.
Berenson wrote: “Using a broader definition, which may include more incidental deaths unrelated to COVID infections, the numbers are even worse, with 5,871 vaccinated people dying compared to 570 unvaccinated.”
The United States does not make this information available to the public, and it is unclear whether American public health officials collect it in a comprehensive manner.
“The report also shows for the first time that adults under 50 are now just as likely to be hospitalized for COVID whether they are boosted or unvaccinated.”
Although the report does not provide a comparable hospitalization estimate for persons who were vaccinated but not boosted, the raw figures it does present indicate that those rates are the highest of all.
“Meanwhile, new Covid infections have nearly doubled in Britain in the last two weeks, and now top 60,000 a day.”
Berenson noted that data shows that boosters “provide no protection against hospitalizations in younger persons.”
According to The New York Times, more than 22 million people under the age of 18 in the United States have been fully vaccinated with Pfizer’s vaccine, but the rate of vaccination is declining. Vaccination of children under the age of five is still in demand.
Pfizer and BioNTech were urged by regulators last month to report early data from a three-dose pediatric experiment. Despite not having definitive data on three doses, the FDA was ready to start vaccinating the youngest age group with two doses.
While the reason for the effort’s failure is yet unknown, Pfizer data shows that two dosages were insufficient.
“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, director of the FDA’s Center for Biologics Evaluation and Research, told reporters on a call.
Marks said he hoped the decision would “reassure” people 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.”
On Sunday, when asked about the matter, Bourla said FDA officials were “extremely enthusiastic” for Pfizer to turn the data over, but Pfizer executives refused.were “a little bit reluctant to submit on two doses because we felt that the three-dose [regimen] is what kids will need.”
Data on how a three-dose regimen works for children as young as 6 months will most likely be ready in April, with approval granted in May “if it works,” according to Bourla.
While Pfizer is unsure if its vaccination will be successful enough for children under the age of two, the company claims that its study indicates that it is safe.
According to the most recent data from VAERS, the major government-funded system for reporting adverse vaccination responses in the United States, a total of 1,168,894 adverse events following COVID immunizations were recorded between December 14, 2020, and March 4, 2022.
During the same time period, there were 25,158 reports of deaths and 203,888 reports of serious injuries, including deaths.
Despite the FDA’s unwillingness to release the documents that formed the foundation for Pfizer’s vaccine approval, Pfizer paid the FDA $2.87 million when it submitted its COVID immunization application, according to Pfizer records.
