October 23, 2021

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Pfizer, BioNTech tell FDA vaccine trial had favorable results in young children

Pfizer and BioNTech said Tuesday that they have submitted initial data to the Food and Drug Administration from their vaccine trial on children between 5 and 11 years old.

Pfizer, BioNTech tell FDA vaccine trial
Pfizer, BioNTech tell FDA vaccine trial

The drugmakers said their trial, which included 2,268 participants from that age group, yielded “positive topline results.” The companies said their coronavirus vaccine has “demonstrated a favorable safety profile” among young participants and “elicited robust neutralizing antibody responses using a two-dose regimen.”

A formal submission to request emergency use authorization for the vaccine in children will follow in “the coming weeks,” the companies said. They also plan to make submissions to the European Medicines Agency and regulatory authorities in other countries.

The vaccine is already authorized under emergency use for children ages 12 to 15 and fully approved for people over 16 in the United States. However, infections are climbing among children as parents and schools await more data and information before vaccinating young children.

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President Biden received his coronavirus vaccine booster shot on camera Monday. Here’s what you need to know about the United States’ boosters rollout.
An Arizona judge voided the state’s ban on school mask mandates, in a victory for local officials who have defied Republican efforts to block such requirements around the country.
A federal appeals court made way for New York Mayor Bill de Blasio (D) to implement a vaccine mandate for all school employees, ruling against four educators who had sued to stop it. Thousands of unvaccinated hospital employees in New York could lose their jobs with a statewide vaccine mandate.
A bipartisan alliance is calling on Congress and the Biden administration to strengthen the care — and payment for care — of Americans suffering from long covid, a syndrome that remains only partly understood.

To upgrade treatment and tracking of patients with long covid, the Covid Patient Recovery Alliance says the federal government should create grants for community health centers, primary care doctors’ practices, mental health practitioners and community networks that can screen people — especially those who are uninsured or undocumented.

In a 21-page interim report, the alliance also urges the federal agency that oversees Medicare and Medicaid to take a series of steps to help pay for long-covid treatment and better coordinate such care. Private Medicare health plans, for instance, should add long covid to a set of severe chronic conditions for which patients need special care, the report says. And states should be given extra money temporarily to better coordinate the care of long-covid patients poor enough to be on Medicaid, it recommends.

People with long covid — also known as post covid-19 syndrome — have symptoms that persist for more than a month after they were first diagnosed with the virus and sometimes are debilitating. They span a constellation of symptoms that can include fatigue, breathing trouble, difficulty thinking, headache, heart palpitations, and altered smell and taste.

In February, the National Institutes of Health launched a $1.15 billion initiative over four years for clinical research into long covid. The alliance says other kinds of research is also needed. It urges HHS to conduct a national survey to help understand how common long covid is, the characteristics of people who get it, and whether they have health insurance and access to workers’ compensation if they are too sick to work. It also recommends grants for organizations to develop long-covid registries.

The alliance is led by Mike Leavitt, a former Republican governor of Utah and health and human services secretary, and Nancy-Ann DeParle, a senior health official in the Democratic Clinton and Obama administrations. Brett Giroir, an assistant HHS secretary in the Trump administration who oversaw coronavirus testing, is also involved.