Pfizer and BioNTech said Thursday they are developing a booster shot for their COVID-19 vaccine along with a new vaccine construct targeting the Delta variant.

The companies said real-world evidence from the Israel Ministry of Health showed vaccine efficacy has declined in the six months following vaccination, leading scientists to believe that a booster dose will “likely be necessary to maintain highest levels of protection.”

“These findings are consistent with an ongoing analysis from the companies’ Phase 3 study,” they said. “That is why we have said, and we continue to believe that it is likely, based on the totality of the data we have to date, that a third dose may be needed within 6 to 12 months after full vaccination.”

Pfizer and BioNTech added they expect to publish “more definitive data” soon and submit it to the Food and Drug Administration “in the coming weeks.”

The two companies also outlined plans to test a new vaccine construct focused on combatting the Delta variant.

“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,” they said.

The companies said they expect to begin clinical trials on the new construct in August.

U.S. President Joe Biden on Tuesday announced plans for door-to-door efforts to get more Americans vaccinated after failing to meet his July 4 goal of 70% of all adults to have at least one dose.

As of Thursday, 67.3% of U.S. adults have received at least one dose of a COVID-19 vaccine and 158,287,566 people have been fully vaccinated, representing 47.7% of the total U.S. population, according to the Centers for Disease Control and Prevention.

A total of 33.79 million COVID-19 cases have been confirmed in the United States and 606,439 people have died since the start of the pandemic, according to data gathered by Johns Hopkins University.

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