FDA authorizes monoclonal antibody therapy for emergency use in some patients 12 and older 

May 26 coronavirus news

By Helen Regan, Meg Wagner, Melissa Macaya, Melissa Mahtani and Veronica Rocha, CNN

Updated 0409 GMT (1209 HKT) May 27, 2021
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7:46 p.m. ET, May 26, 2021

FDA authorizes monoclonal antibody therapy for emergency use in some patients 12 and older 

From CNN's Lauren Mascarenhas

The US Food and Drug Administration authorized the monoclonal antibody therapy sotrovimab Wednesday for the treatment of some Covid-19 patients ages 12 and older, who are at risk for severe disease or death.

The authorization is specifically for those with mild-to-moderate Covid-19, who are at risk of getting much sicker – not for those who are already hospitalized or on oxygen therapy. Monoclonal antibodies may worsen outcomes for hospitalized Covid-19 patients who require oxygen or mechanical ventilation, the FDA noted.

“This includes, for example, individuals who are 65 years of age and older or individuals who have certain medical conditions,” the FDA wrote in a statement Wednesday.

The FDA cited data from a clinical trial, in which 7% of patients who received a placebo were hospitalized or died, compared to 1% of participants who received sotrovimab – an 85% reduction. 

Testing also showed that sotrovimab worked against virus variants first identified in the United Kingdom, South Africa, Brazil, California, New York and India. 

“It is important to expand the arsenal of monoclonal antibody therapies that are expected to retain activity against the circulating variants of COVID-19 in the United States,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.

The FDA authorized the treatment to be distributed intravenously by health care providers. Potential side effects include anaphylaxis, rash and diarrhea.

6:53 p.m. ET, May 26, 2021

Senate panel set to explore options to look into Covid-19 origins

From CNN's Ali Zaslav and Ted Barrett

Democratic Sen. Patty Murray on Wednesday called for “clear answers” from the intelligence community on the origins of coronavirus and the Senate Health, Education, Labor and Pensions Committee chairwoman said her panel would explore any additional options it could take. 

She also also praised President Biden’s call for a stepped up intelligence community review of the origins of Covid-19. 

“There are a lot of answers we need about how the U.S. failed to take COVID-19 seriously from the start and respond effectively, which is why we’ve launched an effort within the HELP Committee to learn and apply the lessons of this pandemic legislatively. A better understanding of the origins of COVID-19 could certainly inform our work, so I’m glad the President is reiterating the need for clear answers and we’ll explore whether additional steps are needed from our committee and others,” Murray said in a statement provided to CNN. 

Earlier Wednesday, Biden directed the US intelligence community to redouble their efforts in investigating the origins of Covid-19 after bipartisan lawmakers called for more answers.  

7:03 p.m. ET, May 26, 2021

New Orleans relaxes some Covid restrictions

From CNN’s Jamiel Lynch

Allison Richter is escorted to the bar by volunteer Fern Watters after receiving the Moderna Covid-19 vaccine at The Howling Wolf, a music venue and bar, in New Orleans, on April 13. 
Allison Richter is escorted to the bar by volunteer Fern Watters after receiving the Moderna Covid-19 vaccine at The Howling Wolf, a music venue and bar, in New Orleans, on April 13.  Gerald Herbert/AP

The city of New Orleans has revised some of their reopening guidelines.

Under the new guidelines that start Friday, indoor and outdoor venues are being given what the city is calling a “pathway to larger events.” The guidelines include:

  • Large indoor events will now be allowed with one of the following conditions: 50% capacity without masks and distancing, 100% capacity with masks required, or 100% capacity without masks if individuals provide proof of vaccination or a negative Covid-19 test within 72 hours.
  • Large outdoor events will now be allowed with one of the following options: 75% capacity without masks and distancing, 100% capacity with masks required, or 100% capacity without masks if individuals provide proof of vaccination or a negative Covid-19 test within 72 hours.

CNN has reached out to the city to find out how the proof of vaccination or negative Covid results would be enforced.

Under the new guidelines, gyms can now open at 100% capacity and there will no longer be time limits on alcohol sales. Restaurants and bars can also remove the six-foot table spacing and eliminate table number restrictions, a news release said.

Additionally, the Covid-related ban on second lines and parades will be removed and will be replaced by the traditional event permitting processes within the Department of Safety and Permits, according to the release.

5:35 p.m. ET, May 26, 2021

Children who aren't fully vaccinated still need to wear a face mask, group says

From CNN’s Jen Christensen

Students from Kingdom Kids Child Development Center pet animals during a birthday party at Springfield Baptist Church in the Shaw neighborhood of Washington, D.C., on April 2. 
Students from Kingdom Kids Child Development Center pet animals during a birthday party at Springfield Baptist Church in the Shaw neighborhood of Washington, D.C., on April 2.  Tom Williams/CQ-Roll Call/Getty Images

The American Academy of Pediatrics (AAP) said Wednesday that children who are age 2 or older and not fully vaccinated still need to wear a well-fitting face mask.

The updated guidance recommends children wear a mask at school, in child care programs, at camp, when playing with friends and playing indoor sports and outdoor sports with close contact — if the mask does not become a hazard in a sport like gymnastics. 

Face masks should be used outdoors if the child is in a large group setting, or when it is impossible to keep good physical distance from others. The AAP also recommends they wear one at home if they live with someone who is immunocompromised or at-risk for severe Covid-19.  

“The COVID-19 vaccines are remarkably effective, but we must stay vigilant,” said AAP President Dr. Lee Savio Beers in an organization news release. 

Since children under age 12 are not eligible to get the Covid-19 vaccine yet it’s “smart to be cautious and careful,” she said.  

5:03 p.m. ET, May 26, 2021

NFL expects all teams will have full capacity at stadiums next season

From CNN's Jacob Lev 

National Football League commissioner Roger Goodell said that the league expects full stadiums for all 32 team's next season.

"We do think it will be a much more normal experience than it has," Goodell said on a conference call on Wednesday. "As you know, we had 1.2 million people last year. We do expect full stadiums.”

Goodell said 30 out of the 32 teams in the league would be permitted to play in front of full capacity stadiums. 

"If we were playing today, you may have this also, 30 of our teams will be permitted to play in front of full capacity crowds. Obviously, we are going to be very focused on local and state health officials and putting safety first. We are confident the two remaining teams will follow in time for this regular season and will continue to work with health officials."

New Jersey Gov. Phil Murphy announced on Monday that MetLife Stadium, home of the New York Jets and Giants in East Rutherford, would be permitted to operate at full capacity next season. 

Goodell added, "A tremendous amount of optimism and excitement that we will have full stadiums across our league this year. Fans are clearly excited about getting started."

 

3:03 p.m. ET, May 26, 2021

EU drug regulator asks J&J to carry out more studies on vaccine following reports of a death

From CNN's Lauren Kent in London

The European Union's drug regulator has asked Johnson & Johnson to carry out more studies on their coronavirus vaccine in light of reports that a woman in Belgium suffered a fatal blood clot following her vaccination, a spokesperson from the European Medicines Agency said on Wednesday.

The EU has administered more than 1.3 million doses of the single-shot J&J vaccine — called Janssen — as of May 20, according to the latest EMA data.

"The European Medicines Agency (EMA) is aware of media reports of a blood clot with fatal outcome in a 37 year old woman in Belgium following vaccination with COVID-19 Vaccine Janssen," the EMA spokesperson told CNN in an email. 

"The woman suffered from a blood clot with low platelets (also known as thrombosis with thrombocytopenia syndrome, TTS) and EMA, the Belgian and Slovenian medicines agencies are currently reviewing this first fatal report together with other case reports of blood clots, as part of regular intensified monitoring activities."

The Janssen vaccine is still authorized for use in the EU, but according to the EU drug regulator it "is under additional monitoring, meaning that it is monitored even more intensively than other medicines."

"In order to assess the impact of the possible link between vaccination and TTS, EMA requested the marketing authorisation holder of the Janssen COVID-19 vaccine to carry out a series of additional studies," the spokesperson added. 

"EMA and national authorities will continue to monitor the vaccine’s safety and effectiveness and provide further updates as necessary. EMA and national authorities are committed to ensuring that the vaccine is used as safely as possible."

 

2:21 p.m. ET, May 26, 2021

10 US states have reached Biden's goal of vaccinating 70% of adults against Covid-19, CDC data shows

From CNN's Deidre McPhillips

A member of the U.S. Armed Forces administers a dose of the Pfizer COVID-19 vaccine at a FEMA community vaccination center on March 2 in Philadelphia, Pennsylvania.
A member of the U.S. Armed Forces administers a dose of the Pfizer COVID-19 vaccine at a FEMA community vaccination center on March 2 in Philadelphia, Pennsylvania. Mark Makela/Getty Images

Ten states have now reached the Biden administration’s goal to vaccinate at least 70% of adults against Covid-19 by July 4 with at least one dose, according to data published Wednesday by the US Centers for Disease Control and Prevention. 

Pennsylvania is the latest state to reach this benchmark, joining Connecticut, Hawaii, Maine, Massachusetts, New Hampshire, New Jersey, New Mexico, Rhode Island and Vermont.

In the United States, more than 165 million people – about 49.7% of the population – has received at least one dose of vaccine, and nearly 132 million people – about 39.7% of the population – are fully vaccinated, CDC data shows.

Overall, 289,212,304 total doses of vaccine have been reported administered, about 80% of the 359,849,035 total doses delivered.

That’s about 1.4 million more doses reported administered since Tuesday, for a seven-day average of about 1.7 million doses per day.

Note: Data published by the CDC may be delayed, and doses may not have been administered on the day reported.

2:17 p.m. ET, May 26, 2021

Switzerland will further ease coronavirus restrictions on Monday

From CNN's Niamh Kennedy

Switzerland will further ease coronavirus restrictions on Monday, allowing indoor dining to reopen and no longer requiring people to work from home, the government said in a statement released Wednesday.

"The Federal Council is going further than proposed in the consultation, particularly with regard to events, private gatherings and restaurants. In so doing, it is responding to the improved epidemiological situation," the Swiss Federal Council said in the statement. "Coronavirus case numbers are continuing to fall. In addition, most cantons will have completed vaccinating people at especially high risk by the end of the month."

As of Monday, restaurants will once again be able to serve guests indoors with a maximum of four people per table, according to the statement. Additionally, restaurants no longer have to close between 11 p.m. and 6 a.m.

For public events, the limit on indoor gatherings will increase from 50 people to 100 people, and the limit on outdoor gatherings will increase from 100 people to 300 people.

For private gatherings, the Swiss Federal Council is increasing the limits from 10 to 30 people for indoor gatherings, and from 15 to 50 people outdoors.

"Working from home will be a recommendation rather than a requirement for businesses that carry out weekly testing. A return to the office should be gradual so as not to jeopardise the vaccination process of staff," the government statement added.

The Federal Council will also begin piloting public events from June 1.

2:00 p.m. ET, May 26, 2021

Go There: CNN reports on US travel ahead of Memorial Day weekend and ongoing mask mandates for passengers

As the US continues to reopen, more than 37 million people are expected to travel for the Memorial Day holiday weekend.

Under federal law, travelers are still required to wear masks when using public transportation, including travel by commercial plane, which could potentially set up more conflicts and fights over mask policy during the busy weekend.

CNN’s Pete Muntean was live from Reagan National Airport in Arlington, Virginia. Watch his report: