February 4 coronavirus news

The US Food and Drug Administration (FDA) revised its emergency use authorization (EUA) for Covid-19 convalescent plasma on Thursday, limiting use to convalescent plasma with high antibody levels, and in hospitalized patients early in their disease course. 

Convalescent plasma is used to treat Covid-19, and is made using the blood of people who have recovered from coronavirus infections. It was first approved for emergency use authorization last August.

Under the revised EUA, the treatment can also be used for those with impaired immunity that has left them unable to produce an adequate antibody response.

The updates were informed by new clinical trial data, made available after August 2020.

Convalescent plasma that is not rich in antibodies has not been shown to be helpful in treating Covid-19 and is no longer authorized for emergency use, the FDA said.

The EUA was also updated Thursday to allow for additional tests to be used in the manufacture of Covid-19 convalescent plasma.

The US Food and Drug Administration has scheduled a meeting of vaccine advisors to discuss Johnson & Johnson’s request for emergency use authorization (EUA) for its coronavirus vaccine.

The FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet on February 26.

Johnson & Johnson said earlier Thursday it had applied for the EUA on behalf of its Janssen Biotech vaccine-making subsidiary. The timing means the FDA would not decide on authorization before the end of the month. 

The FDA added that it cannot predict how long it would take to made a decision, but that the agency would review the request "as expeditiously as possible ... while still doing so in a thorough and science-based manner."

The meeting will be livestreamed on the agency's YouTube, Facebook and Twitter channels, and from the FDA website.  

An estimated 631,000 Americans will have died from Covid-19 by June 1, according to the latest forecast from the Institute for Health Metrics and Evaluation (IHME) at the University of Washington. 

The team behind the influential forecast model said a lot depends on the vaccine rollout and the spread of variants. A worst-case scenario could see the death toll go as high as 703,000.

As of Thursday night, the US had reported more than 455,000 Covid-19 deaths, according to Johns Hopkins University data.

The IHME cited a poll showing an increase in the number of Americans willing to get vaccinated, from 54% to 66%. 

“Daily deaths have peaked and are declining. By June 1, 2021, we project that 123,600 lives will be saved by the projected vaccine rollout,” the IHME said.

How to save more lives: If 95% of Americans wore masks, 44,000 more lives would be saved, the IHME said. Currently, mask use is at about 77%. 

And people need to stay put even if they have been vaccinated, the IHME said. If vaccinated people start moving and traveling as normal, 17 states could see rising daily deaths again by April and May.

“The best strategies to manage this period of the pandemic are rapid scale-up of vaccination, continued and expanded mask-wearing, and concerted efforts to avoid rebound mobility in the vaccinated. Some states are lifting mandates rapidly, which poses a real risk of increased transmission as new variants spread and vaccination rates remain comparatively low,” the IHME warned.

The US Food and Drug Administration says it plans to use the current process for updating flu vaccines as a template for authorizing any changes to coronavirus shots, as authorities face the worrying emergence of new variants.

Some background: There are already more than 600 cases in the US of people infected by several different variants that were first seen in other parts of the world. 

The FDA also said it is making plans to help speed the development of new drugs to treat any strains of virus that escape current treatments, including monoclonal antibody therapies.  

The agency has also been checking whether any of the variants can slip past tests.

“For diagnostics, we have been monitoring for new mutations, identifying and working with developers of tests whose performance may be adversely impacted by them,” Woodcock said. “At this time, we believe the risk that these mutations will impact overall testing accuracy of molecular tests is low.”

The United States has reported at least 618 cases of coronavirus variants across 33 states, according to data posted Thursday by the US Centers for Disease Control and Prevention.

The vast majority (611) of these cases are the more contagious variant known as B.1.1.7, which was originally detected in the United Kingdom. Florida has the highest count, with 187 cases, and California follows with 145. The rest are scattered across a few dozen states.

In addition, there are five cases of the variant called B.1.351, which was initially seen in South Africa. Two cases are in South Carolina, and three in Maryland.

Lastly, Minnesota has identified two cases of the P.1 strain, first linked to Brazil.

The CDC says this does not represent the total number of such cases circulating in the US, but just those that have been found by analyzing positive samples.

As the debate continues over how to safely bring America's kids back to school, 24 states plus Washington, DC, are now allowing all or some teachers and school staff to receive the Covid-19 vaccine.

Several governors are making teachers a priority — like West Virginia, where all teachers 50 or older who expressed that they wanted the vaccine have already received it, according to Gov. Jim Justice. In Ohio, Gov. Mike DeWine has set a plan to have all teachers vaccinated by the end of February, with the goal of all students returning to classrooms by March 1.

Other states, like Rhode Island and Vermont, are not prioritizing any specialized groups other than health care workers, and are distributing vaccines strictly by age.

Of the 24 states that have now made teachers eligible, there is still the matter of availability. In several of those states, some counties are moving more quickly than others to reach the phase or group numbers that include educators.

Two more states, Alabama and Colorado, will include teachers among those who can be vaccinated starting on Monday.

There are 26 states where teachers are still not eligible to receive the vaccine as a specific group — although some educators might fall into the current age group that state is vaccinating.

About 35.2 million doses of Covid-19 vaccine have been administered in the United States, according to data published Thursday by the US Centers for Disease Control and Prevention.

The CDC reported that 35,203,710 total doses have been administered, about 61% of the 57,489,675 doses distributed.

That’s about 1.3 more administered doses reported since yesterday, which is also the seven-day average of doses administered daily.

About 8.5% of the US population – nearly 28 million people – have now received at least one dose of a coronavirus vaccine. Nearly 7 million people, or 2%, have been fully vaccinated, CDC data shows.

To note: Data published by the CDC may be delayed, and doses may not have been given on the day reported. 

Johnson & Johnson officially asked the US Food and Drug Administration for an emergency use authorization of its Covid-19 vaccine Thursday.

As the FDA looks at the results, it will schedule a public meeting of its Vaccines and Related Biological Products Advisory Committee, an independent group of experts who will also look at the data and make a recommendation that the agency takes into consideration when it makes a decision.

What's next: If the FDA decides to authorize the vaccine, next the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices meets to discuss whether the vaccine should be given to Americans and if so, who should get it first.

This same regulatory process for Pfizer took a little over three weeks; for Moderna it was a little more than two.

The Johnson & Johnson vaccine is a little different than the other Covid-19 vaccines. The vaccine, made through a collaboration with the company's vaccine division, Janssen Pharmaceutical, and Beth Israel Deaconess Medical Center, is delivered in a single shot. Pfizer and Moderna’s require two. It’s considered versatile since it is considered stable for up to three months kept in regular refrigerated temperatures and doesn’t need the deep freeze like Pfizer’s.

Johnson & Johnson's Covid-19 vaccine was shown to be 66% effective in preventing moderate and severe disease in a global Phase 3 trial, according to the company. The vaccine is 85% effective overall at preventing hospitalization and death in all regions where it was tested.

Its efficacy against moderate and severe disease ranged from one country to another: 72% in the US, 66% in Latin America and 57% in South Africa. This was measured starting one month after the shot.

The US government has ordered 100 million doses and Johnson & Johnson said it can meet this commitment by June. 

The biotechnology company Novavax announced on Thursday that the "rolling review" process for authorization of its Covid-19 vaccine is underway in multiple countries. 

The vaccine maker announced that it has started the process with several regulatory agencies, including the US Food and Drug Administration, European Medicines Agency, UK Medicines and Healthcare products Regulatory Agency and Health Canada. 

Rolling review means that the company will submit some completed sections of its application for authorization instead of waiting until the entire application is finished. According to Novavax, the reviews by regulatory agencies will continue while the company completes Phase 3 trials in the United Kingdom and the United States.

"The rolling review of our submission by regulatory authorities of non-clinical data and early clinical studies will help expedite the review process and bring us that much closer to delivering a safe and effective vaccine worldwide," Dr. Gregory Glenn, president of research and development at Novavax, said in the announcement. 

"We appreciate the agencies’ confidence in Novavax based on our early data and the collective sense of urgency to ensure speedier access to much-needed COVID-19 vaccination." 

Novavax announced last week that early results from a Phase 3 trial in the UK show its coronavirus vaccine has an efficacy of 89.3%.