Tag: COVID-19

FDA vows to move ‘rapidly’ to authorize second coronavirus vaccine

Washington Post logo

Agency announcement follows Thursday’s positive review of Moderna’s shot by outside advisers

The Food and Drug Administration said Thursday night that it will “rapidly work toward” emergency authorization of Moderna’s coronavirus vaccine, just hours after agency advisers endorsed the shot. The announcement appeared to pave the way for another weapon against a pandemic that has killed about 310,000 people in the United States.

The FDA statement came after the agency’s vaccine advisory panel voted almost unanimously — 20 in favor, with one abstention — that the benefits of the highly effective vaccine outweighed its risks for people 18 years of age and older. The FDA intends to authorize the vaccine Friday, according to knowledgeable individuals who spoke on the condition of anonymity because they were not authorized to speak publicly about the schedule.

“I just want to make the point of what a remarkable scientific achievement this is, and pay thanks to all the scientists, present and past, who contributed to this,” James E.K. Hildreth, president of Meharry Medical College and a member of the advisory panel, said at the close of the committee meeting on Thursday. “To go from having a [genetic] sequence of a virus in January, to having two vaccines available in December, is a remarkable achievement.” Continue reading.

States report confusion as government reduces vaccine shipments, while Pfizer says it has ‘millions’ of unclaimed doses

Washington Post logo

Officials in multiple states said they were alerted late Wednesday that their second shipments of Pfizer-BioNTech’s vaccine had been drastically cut for next week, sparking widespread confusion and conflicting statements from Pfizer and federal officials about who was at fault.

The reduction prompted concern in health departments across the country about whether Operation Warp Speed, the Trump administration’s vaccine accelerator program, could distribute doses quickly enough to meet the target of delivering first shots to 20 million people by year’s end.

A senior administration official, speaking on the condition of anonymity to discuss internal plans, said the revised estimates were the result of states’ requesting an expedited timeline for locking in their allocations for the following week; notification of how many doses they could order each week was consequently advanced from Friday to Tuesday. Since Pfizer is producing doses daily, the official said, fewer doses were available Tuesday than will be available on Friday. Continue reading.

Where are the ‘continuity of government’ vaccine doses coming from? No one wants to say

DC Health says they aren’t in the District’s allotment, Warp Speed won’t explain

Where is the supply of COVID-19 vaccines coming from for senior officials across government? No one will say.

Days after the White House confirmed that senior officials would receive COVID-19 vaccines to help ensure continuity of government, it remains unclear from where those vaccine doses will originate.

The District of Columbia Department of Health insists the vaccine doses will not come from their allocation. The local government in Washington has been working with neighboring jurisdictions to make sure the residents of Maryland and Virginia who are frontline health care workers within D.C. are able to get vaccines. But that doesn’t appear to extend to federal officials. Continue reading.

FDA authorizes Moderna’s COVID-19 vaccine for emergency use

Axios logo

The Food and Drug Administration has issued an emergency use authorization (EUA) for Moderna’s COVID-19 vaccine, one day after it was endorsed by a panel of independent experts.

Why it matters: The authorization of a second coronavirus vaccine, coming exactly one week after the FDA cleared Pfizer-BioNTech’s vaccine for emergency use, increases vaccine access for millions of Americans and marks another milestone on the country’s path to curbing the pandemic.

Between the lines: Moderna’s vaccine, which the FDA confirmed is safe and has a 94.1% efficacy rate, does not need to be stored at ultracold temperatures and comes in smaller batches, making it easier to distribute to rural areas than Pfizer’s vaccine.

An FDA-approved home COVID-19 test is finally here. Here’s how it works

Yesterday the FDA approved the first over-the-counter at-home rapid COVID-19 test, which is expected to be on major drugstore shelves in January, the Washington Post reported. The test is being hailed as a total game changer, but there are still a few strategic sticking points. Here’s what you need to know about what this new at-home test means for us all.

The test is made by the Australian company Ellume, and it is the first test approved by the FDA that can be taken at home and does not require a doctor’s prescription. Here’s how it works: You use a nasal swab to collect a sample from the inside of your nose and then put the sample on a plastic cartridge that looks similar to a home pregnancy test. The device connects to an app on your smartphone, which then communicates with a lab for analysis, and you get your results in as little as 15 minutes.

The Ellume app also automatically sends your results to the cloud by zip code to help local health officials with tracking COVID-19 rates, but your personal data (allegedly) stays confidential. You will also be able to automatically share your results with healthcare providers if you choose to, according to the Post. This all bodes well for helping us know how many people are sick and where they are. Continue reading.

Rep. Patty Acomb (HD44B) Update: December 17, 2020

Dear Neighbors, 

It’s been an eventful week in Minnesota! The first batch of COVID-19 vaccines arrived in our state on Monday, hopefully marking the beginning of the end of the pandemic. That night, the Minnesota House and Senate passed a COVID-19 assistance package to support working families and small businesses. Governor Walz signed the bill into law yesterday. He also provided an update on the measures that are in place to curb the spread of COVID-19. 

New COVID-19 Assistance  

Earlier this week, we delivered new economic assistance for workers and small businesses. The COVID-19 assistance package we approved extends unemployment insurance for Minnesotans who’ve exhausted their benefits. An estimated 100,000 workers, including those whose federal benefits are set to expire on December 26, will receive 13 additional weeks of coverage.  

The legislation includes $88 million of direct financial support for small businesses that are experiencing economic harm due to the pandemic. Restaurants, bars, gyms, and more are eligible to receive this aid. An additional $14 million will be distributed to movie theaters and convention centers, and $114.8 million will go to counties to provide grants to other impacted businesses. You can find more information here.  

Continue reading “Rep. Patty Acomb (HD44B) Update: December 17, 2020”

McConnell getting much of what he wants in emerging relief deal

The Hill logo

Senate Majority Leader Mitch McConnell (R-Ky.) is getting much of what he wants in an emerging coronavirus relief package, after months of digging in his heels against a demand by Democratic leaders to pass a multitrillion-dollar package that would shore up the ailing finances of state and local governments.

The GOP leader isn’t getting liability protection for businesses and other organizations but McConnell himself last week proposed dropping that controversial item along with another large tranche of funding for state and local government. 

State and local funding was a top priority of Speaker Nancy Pelosi (D-Calif.) and Senate Minority Leader Charles Schumer (D-N.Y.). Continue reading.

Scoop: Vice President Pence to receive televised vaccine shot

Axios logo

Vice President Mike Pence plans to receive his coronavirus vaccine shot on camera Friday morning at the White House to build “vaccine confidence” among the American people, according to an administration official with direct knowledge of the plans.

Driving the news: Details are still being worked out, but Pence wants the TV networks to carry the moment live in the morning, the source said, to maximize the audience for the vaccination.

  • The vice president, who has led the White House coronavirus task force, will be joined by second lady Karen Pence and Surgeon General Jerome Adams. Continue reading.

Sweeping COVID-19, spending deal hits speed bumps

The Hill logo

Negotiations over a $900 billion coronavirus relief bill are running into eleventh-hour snags, threatening to push Congress into a rare weekend session. 

Lawmakers had hoped to clinch a sweeping deal, which would also fund the government through Oct. 1, on Wednesday after the top four congressional leaders signaled that they were closing in on an agreement after months of stalemate. 

But instead lawmakers and staff warned that — while they still thought they would get the agreement — the final stages of the talks are moving slowly as they continue to haggle over the details and field requests for changes.  Continue reading.

‘We want them infected’: Trump appointee demanded ‘herd immunity’ strategy, emails reveal

Then-HHS science adviser Paul Alexander called for millions of Americans to be infected as means of fighting Covid-19.

A top Trump appointee repeatedly urged top health officials to adopt a “herd immunity” approach to Covid-19 and allow millions of Americans to be infected by the virus, according to internal emails obtained by a House watchdog and shared with POLITICO.

“There is no other way, we need to establish herd, and it only comes about allowing the non-high risk groups expose themselves to the virus. PERIOD,” then-science adviser Paul Alexander wrote on July 4 to his boss, Health and Human Services assistant secretary for public affairs Michael Caputo, and six other senior officials.

“Infants, kids, teens, young people, young adults, middle aged with no conditions etc. have zero to little risk….so we use them to develop herd…we want them infected…” Alexander added. Continue reading.