FDA says it’s ‘rapidly’ working toward approval for Covid vaccine

FDA says it’s ‘rapidly’ working toward approval for Covid vaccine

More people in the United States have died this year from Covid-19 than were killed in four years of fighting on the battlefields during World War II, NBC News data shows.

On Thursday, the U.S. again broke single-day Covid-19 records for both reported deaths and cases. The country saw 229,928 new cases and 3,110 deaths. The previous single-day record was just on Wednesday. The rise in cases in large parts of the country has prompted dire warnings about hospital capacity and whether colder weather and the holiday season will help the virus spread.

On Thursday, Pfizer’s Covid-19 vaccine got the recommendation from an independent panel of experts that the FDA authorize it for emergency use. The FDA is not obligated to go along with the panel’s recommendation, but it is widely expected to authorize the vaccine for emergency use promptly.



Tim Fitzsimons

2h ago / 12:38 PM UTC

FDA Commissioners Drs. Stephen M. Hahn and Peter Marks said Friday morning that the regulatory body will “rapidly work toward finalization and issuance of an emergency use authorization” for the Pfizer-BioNTech Covid-19 vaccine after the “positive advisory committee meeting outcome.”

“The agency has also notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution,” Hahn and Marks said. 

The Associated Press

2h ago / 12:45 PM UTC

Australia abandons Covid vaccine after it produced false positives for HIV

CANBERRA, Australia — Australian researchers say they have abandoned development of a potential coronavirus vaccine because it produced false positive results on HIV tests.

A statement said Friday that the University of Queensland vaccine that was to be manufactured at Australian biopharmaceutical company CSL’s Melbourne headquarters proved safe and produced a “robust response” to the virus during initial trials.

But it said the researchers and the government agreed not to proceed further because of the false positive result of some HIV tests due to a protein contained in the potential vaccine.

It was one of five potential vaccines on which the Australian government had signed contracts with developers.

Joe Murphy

4h ago / 11:35 AM UTC

The U.S. sets new Covid case and death records for the second day in a row

On Thursday, the U.S. reported two records: 229,928 Covid-19 cases and 3,110 deaths, driven by large case counts in California, Texas and Florida as well as record case counts in New York and New Jersey, according to an NBC News tally.

In the past week, the U.S. has averaged 209,684 cases and 2,316 deaths. Four weeks ago, the U.S. averaged and 165,665 cases and 1,329 deaths.

These states and territory set records:

  • Nevada, 50 deaths
  • New Jersey, 9,993 cases
  • New York, 11,995 cases
  • Puerto Rico, 32 deaths

Rachel Bluth, Kaiser Health News and Phil Galewitz, Kaiser Health News

5h ago / 10:32 AM UTC

Farmworkers, firefighters and flight attendants jockey for vaccine priority

With front-line health workers and nursing home residents and staff members expected to get the initial doses of Covid-19 vaccines, the thornier question is figuring out who goes next.

The answer will likely depend on where you live.

While an influential federal advisory board is expected to make its recommendations this month, state health departments and governors will make the calls on who gets access to a limited number of vaccines this winter.

As a result, it has been a free-for-all in recent weeks as manufacturers, grocers, bank tellers, dentists and drive-share companies all jostle to get spots near the front of the line.

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted 13-1 this month to give first vaccination priority to health care workers and residents of long-term care facilities after one or more Covid-19 vaccines are approved for emergency use by the Food and Drug Administration. The advisory committee is expected to provide further details of its list of prioritized recipients before year’s end.

Its next recommendations are likely to focus on prioritizing people who keep society functioning, like workers in food and agriculture, public safety and education. Older people and those with chronic diseases are also considered to be high on the list.

Read full story here.

Reuters

4h ago / 11:24 AM UTC

Sanofi and GSK delay Covid-19 vaccine, marking setback for global fight

Sanofi and GlaxoSmithKline said clinical trials of their Covid-19 vaccine showed an insufficient immune response in older people, delaying its launch to late next year and marking a setback in the global fight against the pandemic.

The announcement on Friday, which highlighted the challenges of developing shots at record speed, hinders efforts to develop the multiple options that experts say the world needs to counter a disease that has killed over 1.5 million people.

The news, which came on the same day as Australia axed a domestic vaccine project, is also a blow for many governments that have booked hundreds of millions of doses of the shot, including the European Union, United States and Britain.

The two companies said they planned to start another study next February, hoping to come up with a more effective vaccine by the end of 2021.

The setback affects one of the most established technologies in vaccines — used against the human papillomavirus, hepatitis B and pertussis among other pathogens — which aims to introduce lab-made proteins into the body to prod the immune system into developing a targeted defense against the novel coronavirus.

It cements the lead of more novel approaches used by vaccines from the likes of Pfizer-BioNTech and Moderna, which use mRNA genetic technology to trick the body into producing those proteins. Both of those shots were found to be about 95 percent effective in successful large-scale trials.

Read More