NEW YORK, N.Y. (July 9) – Based on evidence of increased risk of reinfection six months after inoculation and the emergence of the extremely contagious Delta variant, Pfizer Inc plans to petition US regulators to approve a booster dosage of its COVID-19 vaccine within the next month, the drugmaker’s chief scientist said on Thursday. The recently observed drop in vaccination effectiveness in Israel, according to Pfizer Chief Scientific Officer Mikael Dolsten, is primarily attributable to infections in persons who were immunized in January or February. In June, the country’s health ministry reported that vaccine effectiveness in preventing infection and symptomatic disease had dropped to 64%.
In an interview, Dolsten stated, “The Pfizer vaccine is particularly active against the Delta form.” “There is likely the possibility of reinfection after six months as antibodies, as predicted, fade,” he said.
Pfizer did not share the entire set of Israeli data on Thursday, but promised to do so shortly.
“It’s a small data set,” Dolsten said, “but I believe the trend is correct: six months out, given that Delta is the most contagious variation we’ve observed, it can cause infections and moderate illness.”
Pfizer’s own data from the United States showed that the vaccine’s efficacy had eroded to the mid-80s after six months against the variations that were circulating in the spring, according to Dolsten.
He emphasized that research from Israel and the United Kingdom suggests that the vaccination is still 95 percent effective against serious disease, despite falling antibody levels.
In a clinical experiment conducted last year, the vaccine, produced with German partner BioNTech SE, showed 95 percent efficiency in avoiding symptomatic COVID-19.
According to Dolsten, preliminary evidence from the company’s own trials shows that a third booster dose results in antibody levels that are five to ten times higher than after the second dose, implying that the third dose will provide promising protection.
Pfizer has already been approached by a number of nations in Europe and internationally to consider booster doses, and some may begin providing them ahead of a potential US approval, he said.
Booster shots, according to Dolsten, are especially important in older age groups.
Pfizer forecasts $26 billion in revenues from the COVID-19 vaccine in 2021, indicating that it will be a key revenue driver for years. According to IQVIA Holdings, a U.S. health data organization, global investment on COVID-19 vaccinations and booster doses might reach $157 billion by 2025.
Dr. Eric Topol, a professor of molecular medicine and director of the Scripps Research Translational Institute in La Jolla, California, believes that basing the decision on waning antibody protection ignores the importance of other components of the immune response, such as memory B cells, which can make antibodies on demand when challenged by the virus.
“To be able to say that, you’ll need more research. It’s not only about neutralizing antibodies, either “Topol stated the following.
Pfizer aims to start a 10,000-person placebo-controlled effectiveness trial of the booster soon. According to Dolsten, the trial will last until the end of the fall, which means it will not be completed in time for the company’s FDA application.
Even if Pfizer is successful in getting its booster approved for use by the FDA, according to Dr. William Schaffner of Vanderbilt University Medical Center, that is only the first step. Advisers to the US Centers for Disease Control and Prevention would still have to review and endorse the booster.
“By no means is it automatic,” he remarked. Most of the public health bandwidth in the United States, according to Schaffner, is still concentrated on urging Americans to receive their first and second doses of the vaccination.
Pfizer’s efforts were met with silence by the FDA.
Pfizer is exploring at methods to increase production since boosters will drive up demand for vaccines because so much of the world is still unvaccinated, according to Dolsten.
It plans to produce 3 billion doses this year and 4 billion doses the next year. Dolsten wouldn’t say how many additional dosages the company could add, but he did say that “in ’22, we can go up billion after billion.”
People will almost certainly require a booster dose, according to Pfizer. However, several experts have questioned whether or not they will be required.
Dolsten also stated that Pfizer and BioNTech are working on a new version of the vaccine that will target the Delta variation, but that the present version will not need to be replaced to battle the variant./n
