Pfizer seeks FDA approval for 3rd COVID jab in response to Delta

Pfizer and BioNTech announced on Thursday that they were developing a version of the coronavirus vaccine that targets the Indian Delta variant, which has spread to nearly 100 countries.  

The U.S.-based company expects to begin clinical trials of the vaccine in August. 

The drug maker is looking to speed up the approval for a third booster dose of its COVID-19 vaccine to target the Delta variant and will request emergency authorization from the U.S. Food and Drug Administration in August, Pfizer research head Mikael Dolsten told Bloomberg. 

“Initial data from human studies has been promising, showing that a third dose is not only safe but can greatly increase immune protection against the virus,” he added. 

Results indicate that a third dose can raise neutralizing antibody levels by five to tenfold compared with the original vaccine, according to Dolsten.  

The data has not been published, neither has it been peer reviewed.  

Once the American pharmaceutical and biotechnology company has collected more data, it plans to request for FDA to authorize a booster shot that could be administered to patients six to eight months after they received their original two doses.  

Pfizer, which produces the vaccine in partnership with BioNTech, is also negotiating with regulators in the European Union and other countries about its results so far. 

The company’s results are based on an initial group of roughly 10 to 20 people who received the booster, and “the data set is so clear, we have complete confidence that the full study will reproduce this,” according to Dolsten. 

“There is a lot of fear and concern” about variants, he told the outlet. “We are confident that such a boost will be highly effective against the Delta variant.”  

A study by Israel’s health ministry this week indicated that the Pfizer jab was 93 percent effective at preventing severe illness and hospitalization from Delta, but only 64 percent effective at protecting against infection from the variant. 

In parallel to Pfizer’s efforts, Moderna and Johnson & Johnson have both said that early data showed their jabs produced antibodies against Delta.