Overnight Healthcare

Overnight Health Care: Battle lines drawn over Biden's support for vaccine waivers | Pfizer, BioNTech seek full FDA approval of COVID-19 vaccine | Top CDC official who warned of pandemic disruption will resign

Welcome to Friday's Overnight Health Care. If you're in need of some heartwarming news: Almost 30 families reunited at MetLife Stadium in New Jersey after more than a year apart due to the pandemic in an event sponsored by United Airlines, Marriott Bonvoy and CLEAR. 

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Today: President Biden's backing of vaccine patent waivers has divided the pharmaceutical industry and Republicans against Democrats and progressive groups. Pfizer and BioNTech officially began their application for full FDA approval for their vaccine, and a top CDC official, who issued an early warning about the pandemic, is leaving the agency.

 

We'll start with waivers:

Battle lines drawn over Biden's support for vaccine waivers

Battle lines are forming over President Biden's move to support waiving patents for COVID-19 vaccines ahead of a contentious push to increase global vaccine access.

The pharmaceutical industry and congressional Republicans blasted Biden's announcement on Wednesday, saying it undermines incentives for American innovation and will not actually solve the complex problem of getting more doses to lower-income countries.

But Democrats and progressive groups lauded the move, which they had been pressuring Biden to make for weeks, and expressed hope that it is a sign of further action to lower drug prices and take on the pharmaceutical industry. 

How soon will there actually be an effect? It is not clear that the waiver proposal will make it through the World Trade Organization. Other countries need to agree, and Germany, for example, raised concerns on Thursday. Negotiating an agreement could take months. 

Read more here.

 

Pfizer, BioNTech seek full FDA approval of COVID-19 vaccine

Pfizer and its German partner company BioNTech announced they started their request for the FDA to grant full approval of their COVID-19 vaccine after having emergency use authorization for almost five months.

The companies said they started their Biologics License Application (BLA) for the FDA to grant full authorization to give their vaccine to those 16 and older.  

What does full approval mean? With the FDA's full approval, the Pfizer-BioNTech vaccine could still be given to patients 16 and older after the public health emergency is declared over.

The Pfizer-BioNTech vaccine, which was the first to receive the FDA's emergency use authorization in December, would become the first vaccine to be granted full approval in the U.S. 

What's next? The companies said they intend to submit data for the BLA "on a rolling basis over the coming weeks" and request priority review for a decision to be made in six months, instead of the typical 10 months.

Pfizer and BioNTech have to submit data on their manufacturing processes, facilities and pre-clinical and clinical trial data. 

A planned decision date will be set after the FDA officially accepts the completed application. 

Read more here

 

CDC warns virus can spread more than six feet under certain conditions

The Centers for Disease Control and Prevention warned in a document published Friday of "repeatedly documented" instances of coronavirus spreading through the air to people more than six feet away under certain conditions.

The new document, explaining the latest understanding of how the virus spreads, is part of a shifting emphasis towards airborne transmission of the virus.

"Transmission of SARS-CoV-2 from inhalation of virus in the air farther than six feet from an infectious source can occur," the new document says in large letters, while also noting it is "less likely than at closer distances."

The risk of this kind of spread is highest indoors in places with "inadequate ventilation," when people are shouting or singing, or when people are exposed for long periods of time, the CDC said.

Some experts have been pushing the CDC for months to place a greater emphasis on airborne transmission and the need to improve ventilation, even with something as simple as opening the window in a room. Experts have also long said that outdoors is far safer than indoors.

Read more here

 

Top CDC official who warned of pandemic disruption will resign

A senior health official at the Centers for Disease Control and Prevention (CDC) who was one of the first to publicly sound the alarm about the coronavirus pandemic said Friday that she will resign next week.

In an email to colleagues seen by The Hill, Nancy Messonnier said her resignation is effective May 14 and that she will become executive director of pandemics and health systems at the Palo Alto-based Skoll Foundation.

Messonnier's resignation was first reported by The Washington Post.

Flashback: Messonnier garnered national attention last year when she contradicted the White House's efforts to dismiss the severity of the novel coronavirus, which was spreading rapidly overseas.

On Feb. 25, 2020, Messonnier warned that the U.S. should prepare for a "severe" disruption to everyday life.

Read more here

 

WHO authorizes China's COVID-19 vaccine for emergency use

The World Health Organization (WHO) on Friday authorized China's Sinopharm COVID-19 vaccine for emergency use, expressing hope that it will boost global access to doses.

The move clears the way for the vaccine to be included in the WHO's worldwide COVAX program.

What this means: "The addition of this vaccine has the potential to rapidly accelerate COVID-19 vaccine access for countries seeking to protect health workers and populations at risk," Mariângela Simão, WHO assistant director-general for access to health products, said in a statement. "We urge the manufacturer to participate in the COVAX Facility and contribute to the goal of more equitable vaccine distribution."

The WHO said the efficacy for the vaccine is estimated at 79 percent, though there are limitations in the data for people over 60 years old, because few in that age group were enrolled.

Still, the WHO said it is not limiting its authorization because "preliminary data" support use of the vaccine in older people as well.

Read more here

 

What we're reading

Covid testing has turned into a financial windfall for hospitals and other providers (Kaiser Health News

As the Covid-19 crisis ebbs in the U.S., experts brace for some to experience psychological fallout (STAT)

In Covid vaccine data, L.G.B.T.Q. people fear invisibility (The New York Times)

 

State by state

Texas health officials earmark  $10M  for local groups to encourage COVID-19 vaccinations (Austin American-Statesman)

Michigan won't count kid vaccinations in data tied to easing COVID-19 restrictions (Detroit Free Press)

5,000 COVID-19 victims; Kelly orders flags at half-staff (The Associated Press)

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