February 25 coronavirus news

US Food and Drug Administration vaccine advisers are scheduled to meet Friday to discuss the potential emergency authorization of a third coronavirus vaccine for the US, this one made by Johnson & Johnson’s vaccine arm Janssen Biotech.

It’s the next step in a process that could end up with the new vaccine’s rollout early next week. As with the two currently authorized vaccines, advisers and federal agencies are meeting over a weekend to try to get the vaccines to the US public as soon as possible.

The FDA has already considered the advanced, Phase 3 clinical trial testing data presented by Janssen and says it shows the vaccine is safe and effective. The Vaccines and Related Biological Products Advisory Committee or VRBPAC is made up of vaccine experts and other medical professionals, industry and consumer representatives who will consider presentations from FDA about its findings, as well as from Janssen. They’ll also hear the latest from the Centers for Disease Control and Prevention about the spread of the virus, including worrying new variants, and on the CDC’s surveillance for any safety worries from the currently authorized vaccines made by Pfizer/BioNTech and Moderna. 

About the timing: The VRPBAC will vote Friday on whether to recommend FDA emergency use authorization (EUA), and the FDA will then take that vote into consideration in deciding whether to authorize the vaccine.

On Sunday, a second advisory group weighs in. The CDC’s Advisory Committee on Immunization Practices (ACIP) will look at all the same data and will discuss whether people should get the vaccine and if so who, and when. A vote is expected by 3 p.m. ET from ACIP. The CDC then takes the ACIP vote into consideration and the CDC director – who is currently Dr. Rochelle Walensky – will decide whether the vaccine has her agency’s OK.

After that, distribution can begin. The White House has promised to begin distribution immediately, with 2 million doses going to states and the rest directly to pharmacies and community health centers. The federal government has said it expects to have up to 4 million doses of Johnson & Johnson vaccine on the first day. The company has promised to ramp up production to deliver 20 million doses by the end of March and 100 million doses by the end of June.

While Pfizer and Moderna’s vaccines require two doses for full efficacy, the Johnson & Johnson vaccine requires only one dose, although the company is testing at two-dose regimen to see if it works any better.

Johnson & Johnson’s data indicates its vaccine was 66% effective across all global trials in preventing moderate to severe Covid-19 disease 28 days after immunization. It was 85% effective in preventing severe disease. No one who got the vaccine died from Covid-19. 

Pfizer plans to begin testing its Covid-19 vaccine in children as young as 5, Pfizer Chairman and CEO Albert Bourla said Thursday. Bourla said that data on this population should be available by the end of the year.

Pfizer finished enrolling people ages 12 to 15 in its adolescent trial for the Pfizer/BioNTech Covid-19 vaccine in late January. Bourla said he hopes that data will be available in a couple of months.

“We are also planning to initiate pediatric studies from younger ages, from 5 all the way to 11, and I believe that we should have data about this population by the end of the year,” Bourla told NBC News’ Lester Holt.

A third shot of the Pfizer/BioNTech Covid-19 vaccine could induce 10 to 20 times the antibody response of the first two doses, Pfizer Chairman and CEO Albert Bourla said Thursday.

Pfizer and its partner BioNTech announced Thursday that they are testing a third dose of their Covid-19 vaccine against new coronavirus variants.

Bourla told NBC News that the company believes a third dose of its vaccine, taken six months after the first, “will raise the antibody response 10 to 20-fold.”

Bourla said the company has confirmed its two-dose vaccine protects against the virus variant first detected in the UK and has data suggesting it protects against the variants first detected in South Africa and Brazil. He added that the data shows the two-dose vaccine still provides robust protection six months out.

Bourla said it likely won’t become a three-dose vaccine.

“We will have an annual re-vaccination, likely with one dose of the vaccine,” he said.

More details: While some researchers have suggested that one dose of the Covid-19 vaccine may be enough, Bourla said that without adequate data, it would be “very high risk” to rely on just one dose of the Pfizer/BioNTech vaccine.

If another Covid-19 variant surfaces, Bourla said the company aims to be able to tweak its vaccine to respond accordingly within 100 days.

 

At least 2,157 cases of coronavirus variants first spotted in the UK, South Africa and Brazil have been reported in the United States, according to data updated Thursday by the US Centers for Disease Control and Prevention.

The vast majority of these cases, 2,102, are the more contagious variant known as B.1.1.7, which was originally detected in the UK. This variant has been found in 43 states, Puerto Rico and Washington, DC. Nearly a quarter are in Florida.

In addition, there are 49 total cases of a variant initially seen in South Africa, called B.1.351, in 14 states and Washington, DC. 

Lastly, six total cases of the P.1 variant first linked to Brazil have been discovered among five states.

CDC says this does not represent the total number of such cases circulating in the US, but rather just those that have been found by analyzing positive samples. The agency cautions that its numbers may not immediately match those of state and local health departments.

Coronavirus cases and deaths are making a “dramatic” decline that is faster than expected, an influential forecasting team said in an update Thursday. The team projects that 574,000 people will have died of Covid-19 in the US by June 1.

Cases and deaths are dropping more quickly than expected – a drop of 70% over the past five weeks, the team at the Institute of Health Metrics and Evaluation (IHME) at the University of Washington reported.

“Daily reported cases in the last week decreased to 65,200 per day on average compared to 96,800 the week before,” the IHME said in its new report.

In its last forecast, the IHME predicted 562,000 Americans will have died by April 1. Currently, according to Johns Hopkins University, 507,806 Americans have died of Covid-19. 

“Despite increasing mobility and the spread of new variants, particularly B.1.1.7, daily cases continue a dramatic decline that began in the second week of January. While the decrease is likely driven by declining seasonality and rising vaccination, it is faster than expected,” it added.

The B.1.1.7 variant, first seen in the UK, has been found across the US and experts fear it might fuel a new surge as it appears to be more contagious. There’s little sign it’s doing so yet, the IHME said.

“Daily deaths are also declining, but the decline is half the size of daily cases,” the IHME said. That may partly be because of a rising ratio of deaths in Alabama, Arizona, California, Delaware, and Georgia. But the number of daily deaths has dropped nearly 35% in the last five weeks.

“In our reference scenario, which represents what we think is most likely to happen, our model projects 574,000 cumulative deaths on June 1. This represents 76,000 additional deaths from February 22 to June 1,” it said.

“Daily deaths are expected to decline steadily until June 1. By June 1, we project that 88,600 lives will be saved by the projected vaccine rollout.”

One other big factor in the slowed spread: Americans are wearing masks. “Mask use has fortunately remained high, with more than three-quarters of adults reporting they wear a mask when leaving home. As new variants likely spread, the behavioral response will be critical in determining if there will be an increase in cases and deaths in April and May. In our worse scenario, where mask use begins to decline this month, infections and detected cases may remain at current levels until late April,” the IHME said.

IHME estimates that 165.82 million Americans will have been vaccinated by June 1 – close to half the population. 

“COVID-19 remains the number 1 cause of death in the United States of America this week,” the IHME said. “We estimated that 19% of people in the United States of America have been infected as of February 22.”

It’s possible a single dose of coronavirus vaccine might be enough to protect people who have recovered from a bout of Covid-19, National Institutes of Health Director Dr. Francis Collins said Thursday.

“It does look as if in those individuals, a single dose, basically it's a booster for them because they already had the infection, they already have some antibodies that may be sufficient and they may not need the second dose,” Collins told CNN’s chief medical correspondent Dr. Sanjay Gupta. 

Collins said that the NIH is “trying to collect as much data as possible about that right now.” 

But, overall, he said that a single dose strategy for everyone could result in unforeseen consequences. “Are those people who are in between first and second actually sitting ducks for getting infected?” Collins asked.

“Is that actually a way that we might encourage more mutations to happen because they're only partly protected? The virus has a chance to live a little longer in their system and pick up some changes," he said.

Collins said that until the data showed otherwise, the authorized two doses three to four weeks apart is the regimen that should be followed.

New, more contagious variants of the coronavirus could fuel a renewed surge of infections, the director of the National Institutes of Health said Thursday.

“Right now, it does look as if in the United States, we're at some risk of another surge due to this variant called B.1.1.7,” NIH Director Dr. Francis Collins said in an interview with CNN’s chief medical correspondent Dr. Sanjay Gupta. The B.1.1.7 variant was first identified in the UK and it has turned up in 43 states, Puerto Rico and Washington, DC, according to the US Centers for Disease Control and Prevention.

Collins noted that the US is on a downward trend of cases and hospitalizations from Covid-19. But that may not last.

He also pointed out that vaccinating residents of long-term care facilities may have had an impact on the drop in hospitalizations.

“That may partly now account for the fact that we are seeing a drop in serious illnesses, but we are nowhere near out of the woods,” Collins said.

He told Gupta that while vaccination efforts can reduce infection rates, it will take time.

“Our best hopes in the interim is for people to do the other things to limit that transmission, like wearing your mask and not congregating indoors,” Collins said.

Missouri will soon enter an eligibility phase for Covid-19 vaccination that will allow school teachers and other essential workers to get vaccinated starting March 15, Gov. Mike Parson said at a news conference Thursday.

Phase 1B — tier three of the state’s Covid-19 Vaccine Plan — makes eligible K-12 educators and school employees, child care providers, grocery store employees and critical infrastructure workers in energy, food, agriculture, and other sectors, Parson said. The new phase makes approximately 550,000 more Missourians eligible to be vaccinated, he said.

“We have prioritized saving lives first and foremost. This is exactly why we started with our health care workers, our first responders and our most vulnerable population,” the governor said. “Tier three represents another very important part of our society. They are the workers in many of the industries we depend on each day to keep our day to day lives operating normally."

The supermarket chain Giant Eagle, Inc. today announced a partnership with the Pittsburgh Steelers to host a multi-day Covid-19 vaccination clinic at Heinz Field, according to a release from Giant Eagle.

The clinic will run from March 2 through March 5 with a “significant number” of appointments available each day, but if additional vaccine supply is made available, the clinic will be extended with additional appointments, the release said.

In order to take part in the Heinz Field vaccination clinic, patients have to have an appointment and qualify under Pennsylvania’s expanded Phase 1A criteria. Appointments will be made available through Giant Eagle’s online scheduling tool starting Friday, according to the release.

“We are excited to partner with the Steelers organization to make ongoing vaccination opportunities accessible to neighborhoods surrounding the city by hosting this clinic at Heinz Field,” Giant Eagle spokesperson Jannah Jablonowski said. “Giant Eagle Pharmacy is committed to supporting the comprehensive care of our communities, and we are pleased to do our part to increase access to the COVID-19 vaccine throughout Western Pennsylvania.”