Morning Rounds Shraddha Chakradhar

G-7 leaders pledge 1 billion vaccine doses to be shared with the rest of the world

In response to pressure to address global inequities in vaccine access, leaders gathered at the G-7 summit in England are committing 1 billion Covid-19 vaccine doses to be shared with lower-income nations. Half of the newly committed doses will come from the U.S., while another 100 million will come from the U.K. The White House struck an urgent deal with Pfizer to make the company's vaccine available to 92 lower-income countries as well as the African Union, marking the first time mRNA vaccines will be available to many of these countries. The commitment of 500 million Covid vaccine doses is on top of the 80 million doses the U.S. has already pledged to share by the end of June. The new shipment will be made available starting in August, with 200 million expected to be shared by the end of the year, while the rest will be shipped in the first half of 2022. 

Officials flag rare heart inflammation cases after Covid vaccination in young people

Officials at the CDC and the FDA said yesterday that they are seeing rare but higher-than-expected cases of a heart inflammation condition known as myocarditis in teens and young adults who got their second shot of one of the mRNA Covid-19 vaccines. While the data are preliminary and the agencies are still investigating whether there is indeed a link, 573 cases of myocarditis and pericarditis — inflammation of the tissue around the heart — were recorded across age groups after the second shot of either mRNA vaccine. That's compared to 216 cases recorded after the first dose. Most who developed myocarditis have fully recovered, agency officials said.

In other vaccine news, Johnson & Johnson announced that U.S. regulators had agreed to extend the expiration date of millions of vaccine doses by six weeks. State officials had warned that J&J doses shipped in February would expire by the end of this month, but an FDA review concluded that those doses were safe for a total period of 4.5 months, which makes them OK to use until mid-August. 

FDA accuses company of distributing unapproved Covid test and using falsified data

The FDA announced yesterday a Class 1 recall — its most serious kind — of a coronavirus rapid antigen test, alleging that the company behind them was selling them without regulatory approval and was using falsified data to inflate the tests' performance, STAT contributor Kathleen McLaughlin reports in an exclusive. The Class 1 designation indicates that using a product may result in serious injury or even death. “Our inspection revealed that the SARS-CoV-2 Antigen Rapid Qualitative Test has been distributed in the United States without marketing approval, clearance, or authorization from FDA,” the agency wrote in a warning letter to Pasadena, Calif.-based Innova Medical Group, which makes the tests. It's not known how many of the test kits were distributed or to whom. Company officials did not respond to a request for a comment. 

Inside STAT: Advocates blast the FDA for not moving as fast on ALS as on Alzheimer’s

ALS advocates protest outside the White House for access to experimental ALS treatments in May 2020. (MIKE HENSON)

With this week's approval of the Alzheimer's drug Aduhelm, ALS advocates are outraged and wondering: Why not the same for us? Aduhelm received an "accelerated approval" based on surrogate endpoints that indicate brain plaques were eliminated rather than showing the drug helps cure or treat the disease itself. But when the FDA's Patrizia Cavazzoni was asked if something similar could be done for ALS, she said no similar surrogate endpoints existed for that disease, prompting swift backlash from the ALS community. Her comments, the chief mission officer of the ALS Association tells STAT's Nicholas Florko, “... underscore our concern that the FDA is not focused enough on the needs of people with ALS and not following its own guidance.” STAT+ subscribers can read more here

NIH releases a plan to confront structural racism. Critics say it’s not enough

The NIH yesterday unveiled a plan to help close the funding gap that separates white and non-white researchers who get research money from the institution. The agency is the largest funder of biomedical research in the U.S., but data has shown Black researchers get NIH funding at roughly half the rate as white scientists. As part of the new plan, the agency plans to expand a mentoring program for scientists of color and increase funding for subjects more often studied by minority researchers, such as health disparities. But critics are pushing back. “Health care disparities are important, but Black [investigators] are also interested in robotics, gene therapy, and CRISPR,” one expert tells STAT, adding, “In some ways, that’s pigeonholing us. That’s saying you should tell a young Black girl who wants to study nanotechnology to study health disparities instead.”

Childhood vaccinations are still not at pre-pandemic rates, CDC report finds

While many routine childhood vaccinations were missed during the early part of the pandemic in the U.S., a new CDC report finds that these vaccinations didn't return to pre-pandemic levels with the lifting of stay-at-home orders. The report included data from 10 U.S. states and cities — including New York City and Michigan. There was a substantial decrease in essential childhood vaccines, including Tdap and the MMR vaccines, during March-May 2020 compared to the same period in 2018 and 2019. Between June-September 2020, once most stay-at-home orders had been lifted, there was still a decline in vaccination rates compared to the two years prior. For instance, there was a nearly 9% decrease in MMR doses in kids aged 1-2 last summer compared to in 2018 and 2019, and a 30% dip in Tdap vaccinations among 12-17-year-olds. 

Covid-19 in the U.S.

Cases yesterday: 14,878
Deaths yesterday: 391

What to read around the web today

  • The CDC’s new leader follows the science. Is that enough? The New York Times
  • Japanese scientists warn that Tokyo Olympics could help spread Covid-19. Science
  • CRISPR treatment for blood diseases shows promise in small study. STAT+
  • The far-right anti-mask movement is coming for Republican governors. Vice News
  • Vertex shelves second drug for inherited lung disease, raising concerns about future growth. STAT+

Thanks for reading! I'm out this weekend, but my colleague Katie Palmer will bring you Monday's newsletter as usual, 

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