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Pfizer begins application for full FDA approval of COVID-19 vaccine

Pfizer and BioNTech announced Friday that they have initiated the process of applying for full FDA approval of their COVID-19 vaccine for people 16 and older.

Why it matters: It's the first coronavirus vaccine to seek a Biologics License Application (BLA), which requires at least six months of data, according to CNBC.


The big picture: The Pfizer/BioNTech, Moderna and Johnson & Johnson vaccines are being administered in the U.S. after receiving emergency use authorization from the FDA.

  • This specific conditional authorization can only be given to vaccines during a public health emergency, and only requires two months of data, NBC News reports.
  • A full approval would allow the Pfizer vaccine to stay on the market after the emergency is declared to be over. The initial FDA review found Pfizer's vaccine to be 95% effective with no serious side effects.

Details: To be considered for full FDA approval, vaccine manufacturers must submit longer-term data on manufacturing, facilities, clinical studies and other information that guarantees that their vaccine is safe and reliable.

  • Pfizer/BioNTech are submitting data to the FDA "on a rolling basis," and a goal date will be set once the BLA is complete and formally accepted for review, according to a press release.

What they're saying: "Following the successful delivery of more than 170 million doses to the U.S. population in just a few months, the BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future," Ugur Sahin, CEO and Co-founder of BioNTech, said in a statement.

  • "We are pleased to work with U.S. regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data."

American Carissa Moore wins first-ever women's Olympic gold in surfing

Team USA's Carissa Moore won gold in the first-ever Olympic women's surfing final, at the Tokyo Games on Tuesday.

The big picture: Brazil's Italo Ferreira won the gold medal in the inaugural men's Olympic surfing contest. The finals were brought forward a day due to the threat of Tropical Storm Nepartak.

Editor's note: This a breaking news story. Please check back for updates.

Activist Tong Ying-kit found guilty of terrorism in first Hong Kong security law trial

Tong Ying-kit, the first person to be charged and tried under Hong Kong's national security law was found guilty of terrorism and inciting secession by three judges Tuesday, per Bloomberg.

Editor's note: This a breaking news story. Please check back for updates.

Naomi Osaka eliminated from Olympic tennis tournament in Tokyo

Tennis superstar Naomi Osaka was eliminated from the Olympics after losing her Tokyo tennis tournament match 6-1, 6-4 in the third round to Czech Marketa Vondrousova on Tuesday.

Editor's note: This a breaking news story. Please check back for updates.

Extreme drought pushes 2 major U.S. lakes to historic lows

Two significant U.S. lakes, one of which is a major reservoir, are experiencing historic lows amid a drought that scientists have linked to climate change.

What's happening: Lake Powell, the second largest reservoir in the U.S., has fallen 3,554 feet in elevation, leaving the crucial reservoir on the Colorado River, at 33% capacity — the lowest since it was filled over half a century ago, new U.S. Bureau of Reclamation data shows.

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North and South Korea restart hotline and pledge to improve ties

North and South Korea's leaders have pledged to improve relations and resumed previously suspended communication channels between the two countries, per Reuters.

Details: South Korean President Moon Jae-in and North Korean leader Kim Jong-un agreed to "restore mutual confidence and develop their relationships again as soon as possible," South Korea's Blue House spokesperson Park Soo Hyun said in a televised briefing, AP notes.

  • This followed an exchange of letters between the two leaders since April.

Go deeper: Kim Jong Un says prepare for "dialogue and confrontation" with U.S.

Editor's note: This a breaking news story. Please check back for updates.

U.S. teen Lydia Jacoby wins Olympic gold medal in 100m breaststroke at Tokyo Games

Team USA's 17-year-old swimmer Lydia Jacoby has won the Olympic gold medal in the women's 100-meter breaststroke at the Tokyo Games.

Of note: The Alaskan is the first American woman to win an Olympic gold medal in Tokyo, and she beat Lilly King into second place.

Editor's note: This a breaking news story. Please check back for updates.

Pelosi expected to extend proxy voting as Delta variant surges

House Speaker Nancy Pelosi (D-Calif.) is expected to extend proxy voting through the fall — and potentially until the end of the year — Democratic lawmakers and aides tell Axios.

Why it matters: The spread of the Delta variant has alarmed both members and staffers anxious about interacting with the unvaccinated. Pelosi’s anticipated move — continuing an emergency COVID-19 measure enacted last year so lawmakers could vote remotely — is aimed at allaying those concerns.

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Jan. 6 panel to paint haunting scene of Capitol attack with graphic footage

The Jan. 6 select committee will paint a haunting picture of what unfolded during the attack on the Capitol during its first public hearing on Tuesday, Axios is told.

Why it matters: The nine-member panel will not only hear from four police officers on the grounds that day, but show graphic video footage similar to the chilling 13-minute video Democrats aired during Donald Trump's second impeachment trial.

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