Health Care

Overnight Health Care: WHO renaming COVID-19 variants | Moderna applies for full vaccine approval | 1.1M NY vaccine passports downloaded since launch

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Today: The COVID-19 variants are getting new names from WHO, Moderna is applying for full FDA approval and a batch of Anthony Fauci emails from earlier in the pandemic is released.

We’ll start with variants:

WHO revising COVID-19 variant naming to avoid stigmatizing countries

The World Health Organization (WHO) announced changes to how it will label COVID-19 variants on Monday, saying the variants will be named using letters of the Greek alphabet instead of the place where they were first discovered.

The WHO declared that variants of interest and variants of concern will receive a designated Greek letter listed on its website.  

Researchers will continue to use the scientific names for each variant, created by Pango and GISAID, because the names include helpful information on the strains. 

Why the change: The naming system was developed after the WHO consulted experts from around the world following concerns that labeling the variants by their location of discovery is “stigmatizing” and “discriminatory.” 

The international health organization predicts the new system “will be easier and more practical” for nonscientists to use. 

“While they have their advantages, these scientific names can be difficult to say and recall, and are prone to misreporting,” the WHO said in a statement. “As a result, people often resort to calling variants by the places where they are detected, which is stigmatizing and discriminatory.”

“To avoid this and to simplify public communications, WHO encourages national authorities, media outlets and others to adopt these new labels,” the statement continued. 

New names: The WHO identifies four “variants of concern,” including B.1.1.7, the variant first discovered in the United Kingdom, which will be called Alpha. The B.1.351 variant first found in South Africa was labeled as Beta, the P.1 variant first discovered in Brazil became Gamma and the B.1.617.2 variant first detected in India is now Delta.

Read more here.

 

Moderna applies for full FDA approval for its COVID-19 vaccine

Moderna on Tuesday said it is applying for full approval from the Food and Drug Administration (FDA) for its COVID-19 vaccine. 

The vaccine is currently authorized under an emergency use authorization, which the FDA has stressed met a very rigorous standard, but applying for full approval is the next step in the process. 

Why does it matter? It could also make it easier for employers, universities and other groups to mandate that people take the vaccine. 

Pfizer applied for full approval, known as a biologics license application, for its vaccine last month, but the process is likely to take time. 

Moderna said it had begun a “rolling submission process” of more data on its vaccine, for full approval for people 18 and older. 

“We are pleased to announce this important step in the U.S. regulatory process for a Biologics License Application (BLA) of our COVID-19 vaccine,” said Stéphane Bancel, Moderna’s CEO. “We look forward to working with the FDA and will continue to submit data from our Phase 3 study and complete the rolling submission.”

Read more here.

 

Fauci: Emails highlight confusion about Trump administration’s mixed messages early in pandemic 

The Washington Post got its hands on some of Anthony Fauci’s early pandemic emails through a Freedom of Information Act request.

Fauci said the emails obtained by the Post reflected “mixed messages that were coming out of the White House” from a host of people who flooded his inbox in the early months of the pandemic.

The Post obtained 866 pages of Fauci’s emails, from March and April 2020, during the first two hectic months after the World Health Organization declared COVID-19 a pandemic and global restrictions on public gatherings shut down much of the world.

Fauci said he was “getting every single kind of question” at the time because people were confused about the “mixed messages” coming out of the White House and wanted to know “the real scoop.”

“I was getting every single kind of question, mostly people who were a little bit confused about the mixed messages that were coming out of the White House and wanted to know what’s the real scoop,” Fauci told the Post in an interview about the emails the newspaper obtained.

“I have a reputation that I respond to people when they ask for help, even if it takes a long time. And it’s very time consuming, but I do,” he added.

The correspondence opens a new window into what it was like for the nation’s top infectious diseases expert to navigate some of the most panic-stricken early weeks of the pandemic.

But: The Post notes that the emails do not show Fauci directly criticizing former President Trump and instead staying in close contact with White House officials.

Read more here

 

Supreme Court denies Johnson & Johnson bid to void $2 billion talc verdict

The Supreme Court turned down an appeal by Johnson & Johnson to void a $2 billion judgment for women who claimed the company’s talc-based products caused ovarian cancer.

The move came in an unsigned order and leaves intact a Missouri state court verdict against the multinational giant. Justices Samuel Alito and Brett Kavanaugh took no part in the consideration of the petition. 

Background: The hefty verdict was the culmination of numerous U.S. lawsuits brought by women who claimed that Johnson & Johnson products contained asbestos and other carcinogens and that the company ignored the health risks.

The initial verdict was for $4.7 billion, but a Missouri appellate court dropped two women from the suit, leaving 20 plaintiffs, and lowering the award to just over $2 billion.

Johnson & Johnson in May 2020 stopped using talc in its baby powder, but the company disputes that its products caused cancer. The company appealed to the Supreme Court in March. 

Related: In 2019, Johnson & Johnson recalled 33,000 bottles of baby powder after the FDA found trace amounts of asbestos in a bottle.

Last year, Johnson & Johnson announced it would stop selling its talc-based products in the U.S. and Canada, citing decreased sales and “misinformation around the safety of the product and a constant barrage of litigation advertising.” 

Read more here

 

1.1M New York state vaccine passports downloaded since launch

More than 1 million New York state vaccine passports have been downloaded onto phones and computers since the platform launched in March.

The New York Times reported Tuesday that approximately 1.1 million Excelsior passes have been issued as of last week since the start of the voluntary program in March.

That number, however, is still far lower than the more than 10.7 million New Yorkers who have been vaccinated, according to state data.

The Excelsior Pass allows venues to scan to verify proof of vaccination or negative COVID-19 test results. It’s downloaded through an app that creates a secure QR code for scanning.

Background: New York Gov. Andrew Cuomo (D) announced the Excelsior Pass in March as “another tool in our toolbox” to fight the spread of COVID-19, while also allowing more areas of the economy to reopen safely. 

New York was the first state to implement a vaccine passport-type platform. Hawaii established a vaccine passport program to allow travel between its islands without testing or quarantines.  

Controversial issue: Vaccine passports have evolved into a controversial and partisan issue, as several Republican governors, including Florida Gov. Ron DeSantis (R), Georgia Gov. Brian Kemp (R) and Alabama Gov. Kay Ivey (R) have signed executive orders banning vaccine passports in their states. 

The White House in April ruled out the Biden administration playing a role in a vaccine passport system.

Read more here.

 

What we’re reading

Anthony Fauci’s pandemic emails: ‘All is well despite some crazy people in this world’ (The Washington Post

Foster and migrant kids shut out from Covid vaccinations (Politico)

Limits of Woodcock’s role highlight need for permanent FDA head (Bloomberg Law

 

State by state

IU Health to require COVID-19 vaccines for employees (Indianapolis Star

Masks after mandate ends? Businesses determine own COVID restrictions as Ohio lifts health orders (The Columbus Dispatch

Birth rate falls in Colorado again, reflecting national trend (Axios Denver)

 

Op-eds in The Hill

Each of us lives in one of two Americas

How did COVID-19 originate? The question may be larger than it looks