Newsman: Covid-19 vaccine maker Pfizer and Moderna, both are now underscore the needs for the third booster shots to protect people from the deadly covid-19 virus stating that it is seeing waning immunity from its coronavirus vaccine.
Drugmaker Pfizer said Thursday it is seeing waning immunity from its coronavirus vaccine and says it is picking up its efforts to develop a booster dose that will protect people from variants. Pfizer and BioNTech have released initial data from a study on booster shots for their COVID-19 vaccine, saying a third dose delivered about six months after the second shot has shown neutralization titers are five to 10 times higher than after two primary doses.
It said it would seek emergency use authorization from the US Food and Drug Administration for a booster dose in August after releasing more data about how well a third dose of vaccine works.
Pfizer said real-world evidence from Israel showed a decrease in efficacy about six months after people were fully vaccinated.
“While protection against severe disease remained high across the full 6 months, the observed decline in efficacy against symptomatic disease over time and the continued emergence of variants are key factors driving our belief that a booster dose will likely be necessary to maintain highest levels of protection,” Pfizer said in a statement.
Moderna, the maker of the only other authorized mRNA vaccine in the U.S., has made similar statements about the need for booster shots in the past.
“Booster shots will be needed as we believe the virus is not going away,” Moderna CEO Stephane Bancel said during a first-quarter earnings call to investors in early May.
Israel’s health ministry said in a statement earlier this week that it had seen efficacy of Pfizer’s vaccine drop from more than 90% to about 64% as the B.1.617.2 or Delta variant spread.
But in an unusual move, two top federal agencies said Americans don’t need boosters yet and said it was not up to companies alone to decide when they might be needed.
Hours after Pfizer issued its statement, the FDA and Centers for Disease and Control issued a joint statement saying Americans do not need booster shots yet.
“Americans who have been fully vaccinated do not need a booster shot at this time,” they said.\
Bottom of Form
Pfizer and its partner BioNTech said evidence was building that people’s immunity starts to wane after they have been vaccinated. The Pfizer vaccine requires two doses to provide full immunity.
“As seen in real world data released from the Israel Ministry of Health, vaccine efficacy in preventing both infection and symptomatic disease has declined six months post-vaccination, although efficacy in preventing serious illnesses remains high,” Pfizer said in a statement emailed to CNN.
“Additionally, during this period the Delta variant is becoming the dominant variant in Israel as well as many other countries. These findings are consistent with an ongoing analysis from the Companies’ Phase 3 study,” it added.
“While protection against severe disease remained high across the full six months, a decline in efficacy against symptomatic disease over time and the continued emergence of variants are expected. Based on the totality of the data they have to date, Pfizer and BioNTech believe that a third dose may be beneficial within 6 to 12 months following the second dose to maintain highest levels of protection.” It gave no further details.
US government officials have stressed that fully vaccinated people have a low risk of infection, even from the Delta or B.1.617.2 variant, which is more transmissible than earlier lineages of the virus.
Plus, several studies have indicated the mRNA vaccines made by Pfizer and Moderna confer long term protection.
“FDA, CDC, and NIH (the National Institutes of Health) are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary. This process takes into account laboratory data, clinical trial data, and cohort data — which can include data from specific pharmaceutical companies, but does not rely on those data exclusively,” they added.
It was a clear message to Pfizer, which has been hinting at the need for a booster shot for months.
The FDA and Centers for Disease Control and Prevention released a joint statement Thursday evening pumping the brakes on the need for a booster shot yet, and encouraged people to get vaccinated in general. Less than 50% of the U.S. is fully vaccinated at this time.
“Americans who have been fully vaccinated do not need a booster shot at this time,” the agencies said in the statement. “FDA, CDC, and NIH (National Institutes of Health) are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary.”
“We continue to review any new data as it becomes available and will keep the public informed. We are prepared for booster doses if and when the science demonstrates that they are needed,” the CDC and FDA said in the statement.
“The United States is fortunate to have highly effective vaccines that are widely available for those aged 12 and up. People who are fully vaccinated are protected from severe disease and death, including from the variants currently circulating in the country such as Delta,” the statement continued.
“People who are not vaccinated remain at risk. Virtually all COVID-19 hospitalizations and deaths are among those who are unvaccinated. We encourage Americans who have not yet been vaccinated to get vaccinated as soon as possible to protect themselves and their community.”
Pfizer said research showed booster doses of its vaccine, developed with BioNTech, produced levels of neutralizing antibodies that are five to 10 times higher than what’s produced after two doses.
“The companies expect to publish more definitive data soon as well as in a peer-reviewed journal and plan to submit the data to the FDA, EMA (European Medicines Agency) and other regulatory authorities in the coming weeks,” Pfizer said in a statement.
And it said it’s also developing a new formulation for a booster dose that may more thoroughly protect people from new variants.
“While Pfizer and BioNTech believe a third dose of BNT162b2 has the potential to preserve the highest levels of protective efficacy against all currently known variants including Delta, the companies are remaining vigilant and are developing an updated version of the Pfizer-BioNTech COVID-19 vaccine that targets the full spike protein of the Delta variant,” the company said. Current vaccines target just a piece of the spike protein — the part of the virus it uses to attach to cells.
“The first batch of the mRNA for the trial has already been manufactured at BioNTech’s facility in Mainz, Germany. The Companies anticipate the clinical studies to begin in August, subject to regulatory approvals.”
The companies are working on materials with a plan to test a new vaccine construct based on the delta variant — with plans to start clinical trials in August.
“While we believe a third dose of BNT162b2 has the potential to preserve the highest levels protective efficacy against all currently known variants including Delta, we are remaining vigilant and are developing an updated version of the Pfizer-COVID-19 vaccine that uses a new construct based on the B.1.617.2 lineage, first identified in India and also known as the Delta variant,” the companies said in a statement.
“The companies are already producing clinical trial material and anticipate beginning clinical studies in August, subject to regulatory approvals,” Pfizer and BioNTech added.
It will be up to the FDA and the Centers for Disease Control and Prevention to determine if and when booster shots will be allowed, recommended and made available.
“Clearly, the pharmaceutical companies have an economic incentive, particularly the ones who have vaccines that are for profit,” Dr. Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center, told ABC News in late May. “We want the decision to be made based on public health solely and [not] on economic incentives of the companies.”
