Tag: COVID-19 vaccine

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.

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.

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.

FDA review clears path for second coronavirus vaccine, this one developed by Moderna

Washington Post logo

NOTE: This article is provided free of charge by the Washington Post.

Regulators, who confirmed the vaccine was 94 percent effective and raised no serious safety concerns, could authorize it as early as Friday

By the end of the week, the United States could have two coronavirus vaccines.

A vaccine developed by biotechnology company Moderna appears poised for regulatory clearance after a detailed data review by Food and Drug Administration scientists confirmed the two-shot regimen was “highly effective” in a clinical trial and carried no serious safety concerns.

The FDA is likely to authorize the Moderna vaccine as soon as Friday, according to a person with knowledge of the situation who spoke on the condition of anonymity because they were not authorized to discuss the issue. Anticipating that decision shortly, Gen. Gustave Perna, who is overseeing the federal effort to distribute vaccines, said Monday that the United States was preparing to ship almost 6 million doses of the Moderna vaccines to 3,285 locations in the first week.

Washington navigates ethical minefield on getting first Covid shots

President Donald Trump, President-elect Joe Biden and leaders in Congress could help themselves to the vaccine in the coming days. The question is: should they?

The first Covid shots will soon be available to top officials and essential staff in the White House, the Pentagon and Congress. But they’re already facing a political and ethical dilemma over who should be at the front of the line.

While most of the scarce Pfizer vaccine is now on its way to hospitals and nursing homes across the country, some of the first tranche was reserved for federal leaders to ensure the government can continue to function as U.S. deaths and hospitalizations peak. President Donald Trump, President-elect Joe Biden and leaders in Congress could help themselves to it in the coming days. The question is: should they?

On Monday, Biden’s transition team said no decision had been made, and that the president-elect is consulting with his chief medical adviser Dr. Anthony Fauci on timing. Trump will hold off for now, but Secret Service agents, the White House medical unit staff and those who run critical operations like the Situation Room will be vaccinated on a staggered basis in the coming weeks, to ensure they don’t all suffer unexpected side effects at once. Congress still is waiting to find out how many doses will be available and when, but some lawmakers are already vowing not to elbow their way ahead. Continue reading.

Here’s Why Vaccinated People Still Need to Wear a Mask

New York Times logo

The new vaccines will probably prevent you from getting sick with Covid. No one knows yet whether they will keep you from spreading the virus to others — but that information is coming.

The new Covid-19 vaccines from Pfizer and Moderna seem to be remarkably good at preventing serious illness. But it’s unclear how well they will curb the spread of the coronavirus.

That’s because the Pfizer and Moderna trials tracked only how many vaccinated people became sick with Covid-19. That leaves open the possibility that some vaccinated people get infected without developing symptoms, and could then silently transmit the virus — especially if they come in close contact with others or stop wearing masks.

If vaccinated people are silent spreaders of the virus, they may keep it circulating in their communities, putting unvaccinated people at risk. Continue reading.

Gov. Walz and Lt. Flanagan Update: December 11, 2020

Minnesota is Ready for COVID-19 Vaccine

On Tuesday, Governor Walz announced that Minnesota is ready to receive and distribute a vaccine effectively, safely, and equitably at the moment it is made available to states.

Throughout the COVID-19 pandemic, Governor Walz has been committed to transparency and accountability, bringing Minnesotans along with him every step of the way as we learn how best to weather this storm. And the vaccine distribution plan distribution plan is no different.

“There are a number of factors outside of our state government control when it comes to getting the vaccine to Minnesotans, including the federal government’s national guidelines on distribution and the supply of the vaccine,” said Governor Walz. “But in Minnesota, we are ready for the vaccine at the moment it becomes available. Our infrastructure is set and our plans are ready to execute. Until then, we need to stay patient, remain hopeful, and keep up the fight.”

Continue reading “Gov. Walz and Lt. Flanagan Update: December 11, 2020”

Gov. Tim Walz urges mask-wearing as bridge to vaccine

Mask use rises; details about vaccines, shutdown expected this week. 

Gov. Tim Walz is urging Minnesotans to stick with mask-wearing as the constant in the state’s COVID-19 response, even as other strategies change against a pandemic that now has caused more than 4,000 deaths statewide.

The governor thanked Minnesotans on Monday for a recent hike in mask-wearing, based on survey data, and said it should be a bridge for the state to a COVID-19 vaccine.

“It makes sense to everyone, being this close to a vaccine, to try and reduce those infections the best we can,” he said. Continue reading.

How 700 Epidemiologists Are Living Now, and What They Think Is Next

New York Times logo

They are going to the grocery store again, but don’t see vaccines making life normal right away.

Even with coronavirus vaccines on the way, many epidemiologists do not expect their lives to return to pre-pandemic normal until most Americans are vaccinated. In the meantime, most have eased up on some precautions — now going to the grocery store or seeing friends outdoors, for example — but are as cautious as ever about many activities of daily life.

In a new informal survey of 700 epidemiologists by The New York Times, half said they would not change their personal behavior until at least 70 percent of the population was vaccinated. Thirty percent said they would make some changes once they were vaccinated themselves.

A minority of the epidemiologists said that if highly effective vaccines were widely distributed, it would be safe for Americans to begin living more freely this summer: “I am optimistic that the encouraging vaccine results mean we’ll be back on track by or during summer 2021,” said Kelly Strutz, an assistant professor at Michigan State University. Continue reading.