Health Care – Pfizer vaccine 80 percent effective in young kids
The Washington, D.C., football team could be moving nearly 30 miles south of the city— down one of the most congested stretches of highway on the East Coast.
Today in health care, Pfizer released some potentially promising data on a vaccine for young kids ahead of FDA advisory meetings next month.
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Pfizer says three doses protect kids under 5
Pfizer and its German partner BioNTech early Monday said three doses of their COVID-19 vaccine triggered a strong immune response in children younger than
5 years old, proving to be about 80 percent effective at preventing symptomatic illness.
The trial was conducted when the highly transmissible omicron variant was dominant. It involved more than 1,678 children under 5 years of age. Children received a dosage that is one-tenth the level an adult would get.
Pfizer said it will complete its request for emergency authorization from the Food and Drug Administration (FDA) this week. The data has not been peer reviewed, and the top-line numbers could change.
Children ages six months to four years are the final group for which no COVID-19 vaccine is authorized. The announcement from Pfizer could be a sign that the long, frustrating wait for parents is nearly over.
The Biden administration initially aimed to have shots for the youngest kids available as early as February, and pressed Pfizer to submit data for just two doses; the idea was that authorization could be expanded to three doses once the data became available.
But Pfizer delayed its request once it became clear two doses did not offer enough protection against omicron.
Upcoming meeting: Moderna is proposing a two-dose vaccine for children ages five and younger, though the company said a booster will eventually be needed. Moderna finished its authorization request earlier this month, but FDA’s outside advisory panel will consider both companies’ requests together at a meeting on June 15.
The agency said it anticipates finishing reviews of both requests within days of each other, so the same day meeting “is the best approach to ensure the most informed recommendations from our external advisors and allow the most optimal decision-making by FDA experts because they will have the comprehensive analyses for both vaccines in the youngest patient populations before them.”
CDC releasing smallpox vaccine for monkeypox
Officials for the Centers for Disease Control and Prevention (CDC) on Monday said the agency is releasing doses of a smallpox vaccine in response to the few recent cases of monkeypox that have been detected in the U.S.
Jennifer McQuiston, CDC’s deputy director for its Division of High Consequence Pathogens and Pathology, said in a press briefing that more than a thousand doses of the Jynneos smallpox vaccine are currently available in the U.S., with more doses expected to become available as production ramps up.
Jynneos, approved by the FDA in 2019, is manufactured by Bavarian Nordic, a biotechnology company headquartered in Denmark.
The vaccines will be designated for people who are most likely to benefit from them, McQuiston said, including those who are known to have had close contact with monkeypox patients, health care workers and people who would be at high risk of developing a severe case of the disease.
The Jynneos vaccine is administered in two 0.5 mL doses four weeks apart.
McQuiston confirmed that there has been a request for the release of Jynneos from the U.S. national stockpile for high-risk contacts and said it was “actively happening right now.”
ONE-THIRD OF AMERICANS IN NEW POLL SAY PANDEMIC IS OVER
One-third of respondents to a Gallup poll published on Monday said they believe the COVID-19 pandemic is over.
The poll found that 34 percent of respondents said the pandemic is over, while 66 percent of respondents disagreed with that sentiment.
There was a stark partisan divide in responses. Sixty-six percent of respondents who are registered Republicans said that the pandemic is over, compared with 10 percent of Democrats and 39 percent of independents.
According to the Gallup poll, the age group most likely to say the pandemic is over is adults between 45 and 64.
Overall, 11 percent of respondents said they believe COVID-19 will disrupt public life for just a few more weeks, compared to 40 percent who said it will continue until the end of the year and 34 percent who said the disruption will last even longer.
Twenty-one percent of respondents said they believe their lives have returned to normal despite the ongoing pandemic, while 50 percent of those surveyed said their lives will never return to normal.
MERKLEY POSITIVE FOR COVID-19, COMPLICATING THE 50-50 SENATE
Sen. Jeff Merkley (D-Ore.) on Monday said he had tested positive for COVID-19, an announcement that could throw a wrench in Democrats’ agenda this week in an evenly divided Senate.
Majority Leader Charles Schumer (D-N.Y.) was expected to schedule a preliminary vote this week on a hotly contested domestic terrorism bill. The legislation passed the House last week largely along party linnes, and Senate Republicans have vowed to block it.
The bill needs 60 votes to overcome a filibuster, and it’s not clear if there will be 10 Republicans who will break ranks. Democratic leaders have typically delayed party-line votes if they know some of their members will be absent.
Merkley said he was a close contact to someone who tested positive, and is experiencing “mild” symptoms, which he attributed to being both vaccinated and boosted.
“This is yet another reminder that COVID-19 is still among us,” Merkley said in a statement. “As Americans make plans before the holiday weekend, I encourage everyone to take steps to make sure the virus is not an uninvited guest.”
At-risk House Dems want ACA assistance extension
A group of vulnerable House Democrats is warning of spikes in ObamaCare premiums this fall, saying enhanced financial assistance from last year’s coronavirus relief bill needs to be extended.
Rep. Lauren Underwood (D-Ill.) led the letter from 26 swing-district House Democrats to Senate Majority Leader Charles Schumer (D-N.Y.) and Speaker Nancy Pelosi
(D-Calif.), calling for the enhanced ObamaCare financial assistance to be extended as part of any party-line economic package that Democrats put together.
Midterm effects: If Congress does not act, experts say, ObamaCare enrollees will receive notices of increases in their premiums in the run-up to the midterm elections, a political blow for Democrats at a time when the party is already facing major electoral headwinds.
The American Rescue Plan, signed by President Biden early last year, provided temporary help paying premiums to ObamaCare enrollees. But those extra subsidies are slated to expire at the end of this year, leading to calls for Congress to act.
“These out-of-pocket cost increases are imminent: starting this autumn, when enrollees begin receiving notices of their premium increases for 2023 health plans, our constituents will find that the same high-quality coverage that they have been able to afford thanks to the American Rescue Plan will now be out of reach,” the lawmakers write.
WHAT WE’RE READING
- The Michigan mink mystery: How did an interspecies outbreak unfold? (New York Times)
- WHO says no evidence monkeypox virus has mutated (Reuters)
- The U.S. just got 70,000 pounds of baby formula airlifted in from Europe to help with the national shortage (Fortune)
STATE BY STATE
- North Carolina Senate Republicans to push for Medicaid expansion (Axios Raleigh)
- Pensacola abortion clinic ordered to close overnight after three women hospitalized (Pensacola News Journal)
- ‘Your lives intersect with ours’: COVID on the rise again in nursing homes (CT Mirror)
That’s it for today, thanks for reading. Check out The Hill’s Health Care page for the latest news and coverage. See you tomorrow.
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