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Thursday, November 26, 2020

FDA commits to high safety standards in coronavirus vaccine review

The Food and Drug Administration’s coronavirus vaccine advisory panel assured the public that the approval process will uphold the highest safety standards to boost confidence.

“Only those vaccines that are demonstrated to be safe and effective” will be licensed by the FDA, said Marion Gruber, director of the FDA’s Office of Vaccines Research and Review.

The Vaccines and Related Biological Products Advisory Committee, or VRBPAC, is made up of 25 outside medical experts specializing in epidemiology and biostatistics. The committee convened for its first digital meeting Thursday and streamed it for the public to watch in hopes of assuring people that the FDA, which relies on advice from the committee, will rely on science and data to determine if the vaccine is safe and effective.

Fewer people than ever would be willing to get a vaccine for the coronavirus if one were available right now out of fear that a vaccine on such an accelerated timeline might not be safe. The apprehension to get vaccinated could foil government efforts to inoculate the majority of the U.S. population, which government health officials say is the only way to return to the pre-pandemic normal.

Health and Human Services Secretary Alex Azar said that all people in the United States could have access to an approved coronavirus vaccine in March or April. He based his assessment on the scale at which the vaccine is currently being produced and not on any data from vaccine trials.

“We believe by the end of [2020], we would have enough FDA-authorized vaccine to vaccinate our most vulnerable people,” Azar said Thursday on CBS This Morning. “By the end [of] January, [we’ll have] enough vaccine for all of our seniors, as well our healthcare workers and first responders, and, by the end of March to early April, enough for all Americans.”

Thursday’s move by the advisory panel also aimed to assure people that politics will be excluded from the review process.

“The FDA frequently convenes outside panels of medical experts for their advice on products,” said Peter Marks, director of the FDA’s center for biological products. “But normally, panels about vaccines are watched by dozens of people. In this case, it’s watched by many thousands.”

Steven Anderson of the FDA’s biological products center added that the FDA will continue monitoring the approved vaccines for serious adverse effects.

President Trump has pushed for swift approval of a vaccine, causing the public to worry that the agency will cut corners under pressure from the White House.

There are nearly 8.4 million confirmed coronavirus cases in the U.S. and almost 223,000 confirmed deaths as of Thursday.

Trump tested negative for the coronavirus while on Air Force One Thursday, according to White House chief of staff Mark Meadows. Trump, who was diagnosed with the coronavirus earlier this month, has resisted disclosing when he last tested negative for the coronavirus.

Trump is in Nashville for the final presidential debate Thursday night at Belmont University.

“We tested him on the way here … and he tested negative,” Meadows told reporters.

Joe Biden also tested negative for the virus Thursday before departing for Nashville.

Wikipedia and the World Health Organization are teaming up to expand access to reliable information about the COVID-19 pandemic, the organization announced Thursday. Through the collaboration, people will have access to all WHO coronavirus resources such as infographics, videos, and other public health assets free of charge.

“Equitable access to trusted health information is critical to keeping people safe and informed during the COVID-19 pandemic,” said Dr. Tedros Adhanom Ghebreyesus, director-general of the World Health Organization. “Our new collaboration with the Wikimedia Foundation will increase access to reliable health information from WHO across multiple countries, languages, and devices.”

New York Gov. Andrew Cuomo flaunted the success of his book, American Crisis: Leadership Lessons from the COVID-19 Pandemic, about his handling of the pandemic. Meanwhile, health officials in Brooklyn, Queens, Rockland, and Orange counties are reporting new outbreaks in certain concentrated areas, or microclusters. State health department findings showed that the positivity test rate in the microclusters is 3.2%, while the average statewide is 1.2%, an increase from the average rates of less than 1% from mid-August through September.

Chicago Mayor Lori Lightfoot announced that a business curfew will begin in the city beginning Friday. She cited a surge in coronavirus cases as the reason for the measure. The limits include a 10 p.m. closing for all nonessential businesses and a last call of 9 p.m. for serving liquor.

According to a report released by Yelp, new businesses are opening at a surprising rate during the pandemic. The review site found that in September, the number of restaurants and food businesses that opened in 2020 was nearly as high as those created in 2019, 6,497 versus 6,624, respectively, despite the extremely different circumstances. This despite the fact the economy contracted at a record-breaking 31.4% annual rate in the second quarter this year.

France will extend curfew to cover about two-thirds of the population just one week after it was enacted to affect nine cities. The update comes as France nears 1 million coronavirus cases since the start of the pandemic.



Read More at Washingtonexaminer

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