November 17 coronavirus news

More Americans are now willing to take a vaccine for Covid-19 – even before Pfizer and Moderna made their vaccine announcements – primarily because of a jump in Democrat willingness, a new Gallup poll found.

The poll, which was conducted between Oct. 19 and Nov. 1, found that 58% of Americans said they would now be willing to take a Covid-19 vaccine. This is up from a low of 50% in September.

The number of people who said that they would not get a vaccine – 42% – is down from 50% in September, but still shows the challenges ahead when it comes to vaccine compliance.

The largest increase in willingness came from Democrats: 69%, compared with 53% in September.

People ages 45 to 64 also had a significant increase, from 36% in September to 49%, although they are still the age group least likely to say they would get a vaccine.

Women and people without college degrees also had 10 point increases in willingness – women going from 44% to 54% and those without college degrees from 45% to 55%.

For Americans who said that they would not get a vaccine, their reasoning included the rushed development timeline (37%), wanting to confirm the vaccine is safe (26%), not trusting vaccines in general (12%), and wanting to wait and see how effective a vaccine will be (10%). An additional 15% gave other reasons, which included the view that the vaccine isn’t necessary, and politicization of a vaccine potentially comprising its safety. 

The US Food and Drug Administration needs to be clearer and more consistent when it gives emergency use authorization to coronavirus treatments and vaccines, the Government Accountability Office said in a report released Tuesday.

The GAO reviewed the entire federal government effort to develop coronavirus vaccines and treatments, and came away with one main message: The FDA needs to do a better job of explaining and justifying its decisions. 

“FDA should identify ways to uniformly disclose to the public the information from its scientific review of safety and effectiveness data when issuing EUAs for therapeutics and vaccines. HHS neither agreed nor disagreed with the recommendation, but said it shared GAO's goal of transparency and would explore approaches to achieve this goal,” the GAO said.

The FDA has not yet been asked to issue an EUA for any vaccine, but at least two companies – Moderna and Pfizer – are expected to apply within days. The FDA has promised a thorough review but the GAO said the agency’s record on granting EUAs to treatment for coronavirus showed it had not always been clear or consistent.

But the FDA appeared to have taken the GAO recommendation on board.

“I am announcing today that our drug and biological product centers intend, to the extent appropriate and permitted by law, to publicly post their reviews of the scientific data and information supporting the issuance, revision or revocation of EUAs for all drug and biological products, including vaccines, as part of our COVID-19 response,” FDA Commissioner Dr. Stephen Hahn said in a statement also released on Tuesday.

Emergency use authorization is a quicker way to get a medical product on the market in a health emergency than the traditional approval process, which can take weeks or months. EUAs are usually time limited and based on less data than full approvals. While the GAO did not accuse the FDA of cutting corners on some of its coronavirus EUAs, it said the FDA could have better explained its decisions.

Some background: The FDA authorized the anti-malarial drugs hydroxychloroquine and chloroquine – and later revoked that EUA – as well as convalescent plasma taken from coronavirus survivors, the antiviral drug remdesivir, and Eli Lilly and Co’s monoclonal antibody bamlanivimab.

Wall Street reversed course on Tuesday, with stocks pulling back one day after reaching new record highs.

Stocks soared Monday after early results from Moderna's Covid-19 vaccine trial indicated its vaccine is highly effective, giving investors plenty of opportunity to take some profits.

Here's how things looked at closing:

More American adults are starting to see so-called normal activities as risky, according to new poll results released by Axios-Ipsos on Tuesday. 

Seventy one percent of Americans now see attending in-person gatherings as a large or moderate risk and 68% have this view on in-person dining at a restaurant. Both these percentages are up from 63% and 61%, respectively, in late October, according to the poll, which was based on a nationally representative survey of 1,092 US adults conducted between Nov. 13 and 16.

The number of Republicans who see in-person gatherings as risky has grown from 40% in late October to 52% now. For indoor dining, the percentage rose from 37% to 45%. 

Three quarters of those surveyed also said they see spending time in public places as the weather gets colder as a large to moderate risk. 

Americans are also starting to stay away from others more, although not to the extent of the first shutdown in April. Sixty percent of those surveyed said have not visited friends or family in the last week and 76% reported social distancing. 

When it comes to the holidays, 75% of Americans see traveling to be risky. The survey found 45% plan to spend holidays within their own households and 8% within a “holiday bubble.” Another 17% said they will spend the holiday with non-household members. 

The poll also looked at public health and state of mind, vaccine interest and trust in President-elect Joe Biden. 

The number of Americans who said they were likely to get a first-generation vaccine when one is available went up from 38% in early October to 45% now. Sixty eight percent said that they would likely get a vaccine that has been proven safe. The poll was conducted after Pfizer’s vaccine announcement and before Moderna’s.

Pfizer has kept both President Trump and President-elect Joe Biden’s teams informed about the development of the company’s coronavirus vaccine, Pfizer CEO Albert Bourla said Tuesday.

Bourla said that he has not spoken personally to Biden, but Pfizer has kept the Biden team in the loop.  

Bourla said that Pfizer has also kept leadership in Congress informed and will continue to do so.

“I don't think it’s ideal that we are starting, like in the middle of a transition,” said Bourla. “It's always better when there is clear accountability and leadership, but I think that that will not become a problem.”

Watch Dr. Gupta report:

Utah passed a new milestone in the coronavirus pandemic Tuesday, as its seven-day average of new Covid-19 cases topped 3,000 for the first time.

The state's department of health announced 3,178 new cases, bringing the rolling one-week average to 3,056.

Utah’s case count for the pandemic is now 158,957, with 732 deaths. All 29 counties are listed as having a “very high rate” of coronavirus.

The Pfizer vaccine trial has reached its safety milestone and the company is preparing to file for emergency use authorization, Pfizer CEO Albert Bourla said Tuesday.

Pfizer announced on Nov. 9 that its coronavirus vaccine appears to be more than 90% effective, based on early data.

But the company did not yet have enough data to seek emergency use authorization from the US Food and Drug Administration, which said it also wanted at least two months of safety data on at least half of a vaccine trial’s volunteers starting from when they got their second immunization.

Bourla said they are not yet sure how durable the protection from their vaccine will be. The Pfizer vaccine uses a messenger RNA, or mRNA, platform to produce an immune response.

“With the mRNA technology, you can boost as soon as you want,” said Bourla. People can be given an additional dose of a vaccine once immunity wears off, referred to as a boost.

Bourla said that a boost, if needed, would likely require only one dose.

France has become the first country in Europe to top two million confirmed cases of coronavirus, according to data from Johns Hopkins University and the French national health agency.

In a statement on Tuesday evening, the country’s health agency director Jerome Salomon confirmed that the cumulative number of coronavirus cases in France now stands at at least 2,036,755.

“This second wave, which we are all facing, is massive, deadly and is straining all of our caregivers and our health system as a whole,” he added.

While France has now registered the highest cumulative number of coronavirus cases in Europe overall, Salomon noted that the current coronavirus reproduction rate in France is now below one, while the daily number of new cases has declined in the last week.

“In recent days, the number of new cases has declined, redoubling efforts to regain control of the epidemic,” Salomon said, adding that public adherence to national coronavirus restrictions is now “beginning to bear fruit” in France.

“All collective efforts, respect for curfews and national confinement measures serve to explain this positive trend. It is by maintaining a very high level of vigilance and mobilization that we will be able to spend the end-of-year celebrations and the winter months in the safest conditions,” he added.

According to the latest data from the national health agency, a total of 33,139 coronavirus patients are currently in hospital – down by 327 since Monday – with 4,838 of those in intensive care.

A further 1,219 coronavirus patients have died since Monday, the national health agency added, bringing the total death toll in France to 46,273.

Production bottlenecks and other shortages could slow efforts to distribute coronavirus vaccines quickly to the American public, the US Government Accountability Office cautioned in a report released Tuesday. 

A GAO review of Operation Warp Speed found several chokepoints in the efforts to develop and distribute any vaccines that may win emergency use authorization from the US Food and Drug Administration. 

They include limited manufacturing capacity, the GAO said.

“Additionally, once bulk quantities of vaccines or therapeutics are produced, they must be sealed into sterile containers, such as vials or syringes, in a process known as fill-finish manufacturing. Experts from three pharmaceutical industry groups we interviewed said there is a shortage of facilities with capacity to handle fill-finish manufacturing, which could lead to production bottlenecks," the agency added.

The pandemic itself also has disrupted the supply chain, the report found.

Plus, good staff can be hard to find: “The ability to hire and train personnel with the specialized skills needed to run vaccine manufacturing processes may be a challenge for even experienced manufacturers. For example, we heard from representatives at a Covid-19 vaccine manufacturing facility that filling open positions for mid- to upper management positions had been a challenge.”

The GAO said it had told the Health and Human Services Department, Department of Defense and other agencies about the problems it found.

“Through Operation Warp Speed, federal agencies and vaccine manufacturers said they are working together to mitigate these challenges,” it said.