Pfizer says it’s time for a Covid recall; FDA and CDC say not so fast

CNN
–

Drugmaker Pfizer said on Thursday it was seeing a decrease in the immunity of its coronavirus vaccine and is redoubling its efforts to develop a booster dose that will protect people against the variants.

He said he would seek emergency use authorization from the United States Food and Drug Administration for a booster dose in August after it released more data on the effectiveness of a third dose of the vaccine.

But in an unusual move, two prominent federal agencies said Americans don’t need boosters just yet and said it’s not up to companies to decide when they might be needed.

Hours after Pfizer released its statement, the FDA and the Centers for Disease and Control released a joint statement saying Americans do not yet need booster shots.

“Americans who have been fully immunized do not need a booster at this time,” they said.

Pfizer and its partner BioNTech said evidence was mounting that people’s immunity began to wane after being vaccinated. The Pfizer vaccine requires two doses to provide complete immunity.

“As real-world data released by the Israeli Ministry of Health shows, the vaccine’s effectiveness in preventing both infections and symptomatic illnesses decreased six months after vaccination, although the effectiveness in preventing prevention of critical illness remains high, ”Pfizer said in a statement to CNN. .

“In addition, during this period, the Delta variant becomes the dominant variant in Israel as well as in many other countries. These results are consistent with an ongoing analysis of the phase 3 study of the companies, ”he added.

“While protection against serious illness has remained high for the full six months, a decline in efficacy against symptomatic illnesses over time and the continued emergence of variants are expected. Based on all of the data available to them to date, Pfizer and BioNTech believe that a third dose may be beneficial within 6 to 12 months of the second dose to maintain the highest levels of protection. He gave no further details.

U.S. government officials have pointed out 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 previous lineages of the virus.

In addition, several studies have indicated that mRNA vaccines manufactured by Pfizer and Moderna confer long-term protection.

“The FDA, CDC, and NIH (the National Institutes of Health) are in a rigorous, scientific process to determine if or when a recall might be necessary. This process takes into account laboratory data, clinical trial data and cohort data – which may include data from specific drug companies, but are not based exclusively on that data, ”they added.

It was a clear message to Pfizer, which has been hinting at the need for a recall for months.

“We continue to review all new data as it becomes available and will keep the public informed. We are ready to receive booster doses if and when science shows they are needed, ”the CDC and the FDA said in the release.

“The United States is fortunate in having very effective and widely available vaccines for people 12 years of age and older. Fully vaccinated people are protected against serious illness and death, including against variants currently circulating in the country such as Delta, ”the statement continued.

“People who are not vaccinated remain at risk. Virtually all hospitalizations and deaths related to COVID-19 are unvaccinated people. We encourage Americans who have not yet been vaccinated to get vaccinated as soon as possible to protect themselves and their community. ”

Israel’s health ministry said in a statement earlier this week that it had seen the effectiveness of Pfizer’s vaccine drop from more than 90% to around 64% as variant B.1.617.2 or Delta worsened. propagated.

Pfizer said research has shown that booster doses of its vaccine, developed with BioNTech, produced levels of neutralizing antibodies five to ten times greater than those produced after two doses.

“The companies plan to publish more definitive data soon as well as in a peer-reviewed journal and plan to submit the data to the FDA, the European Medicines Agency (EMA) and other regulatory authorities in the future. weeks to come, ”Pfizer said in a statement. .

And he said he was also developing a new formulation for a booster dose that could better protect people from the newer variants.

“While Pfizer and BioNTech believe that 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 remain vigilant and are developing an updated version of the Pfizer-BioNTech COVID-19 vaccine. which targets the complete spike protein of the Delta variant, ”the company said. Current vaccines target only part of the spike protein – the part of the virus that it uses to attach to cells.

“The first batch of mRNA for the assay has already been manufactured at BioNTech’s facilities in Mainz, Germany. The companies expect clinical studies to begin in August, subject to regulatory approvals. ”