Overnight Health Care: FDA panel endorses Johnson & Johnson vaccine | CDC director warns decline in cases ‘may be stalling’ | Biden administration buys 100,000 doses of Lilly antibody drug
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Johnson & Johnson’s COVID-19 vaccine is poised for emergency authorization and rollout after being endorsed by an FDA expert panel. It’s good news, but comes as the CDC director issued a somber reminder that we’re not out of the pandemic yet.
We’ll start, as usual, with vaccines:
Help on the way: FDA panel endorses Johnson & Johnson COVID-19 vaccine
It might not be paradise waiting, but the U.S. is likely to get a third COVID-19 vaccine in the coming days. A Food and Drug Administration (FDA) advisory panel on Friday endorsed Johnson & Johnson’s coronavirus vaccine and recommended the agency grant emergency authorization, moving the nation’s third vaccine one step closer to getting into Americans’ arms.
The panel voted 22-0 that the benefits outweigh the risks for adults age 18 and older.
FDA could give the green light to the single-dose vaccine as early as Saturday.
Vaccinations will begin once a Centers for Disease Control and Prevention (CDC) panel recommends the vaccine and the CDC accepts that recommendation. The CDC panel is scheduled to meet Sunday.
White House COVID advisor Andy Slavitt:
NEW: J&J single-dose COVID-19 vaccine supported by FDA Advisory Committee.
FDA meets to finalize Saturday.
A third safe and effective vaccine is very welcome news.
— Andy Slavitt (@aslavitt46) February 26, 2021
The endorsement from the FDA panel of experts comes as federal officials are warning about the impact of recent highly contagious variants of the coronavirus, urging people not to grow complacent.
The rise of variants makes vaccination more important than ever, CDC officials said.
Why it’s important: Every vaccine helps, but the J&J shot has potential to be a real game changer. It’s a single dose, so there isn’t a need to worry about scheduling a follow-up, or running low on supplies. It also does not need to be frozen when shipped and stored.
Starting slow: Johnson & Johnson’s vaccine will only be available at a relative trickle at first. The company will only have about 4 million doses available to ship immediately upon authorization, but that number will increase to 20 million by the end of next month. Moderna and Pfizer/BioNTech, which manufacture the other two vaccines, have also pledged to dramatically increase supply by the end of March.
Some not great news from the CDC director: CDC director warns decline in COVID-19 cases ‘may be stalling’ in ‘concerning shift’
Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky warned Friday that recent declines in COVID-19 cases, hospitalizations and deaths “may be stalling,” calling the trends a “very concerning shift.”
CDC data shows the number of new cases has declined dramatically in recent weeks, from a peak of about 250,000 per day in mid-January to about 60,000 per day.
But now after weeks of falling, the number of new cases has started ticking back up in recent days, and are still at a very high level overall, at about 66,000 new cases per day.
“The latest data suggest that these declines may be stalling, potentially leveling off at still a very high number,” Walensky said during a White House briefing. “We at CDC consider this a very concerning shift in the trajectory.”
Several states have been relaxing restrictions in areas like restaurant capacity, and in some cases mask mandates. Walensky urged states not to lift restrictions, without naming any in particular.
“Things are tenuous,” she said. “Now is not the time to relax restrictions.”
Hope on the horizon, though: Overall, officials said that with vaccinations on the rise, now is not the time to let up on restrictions and taking precautions like wearing a mask and distancing from others, but vaccines could be much more widely available by the spring, helping to more permanently suppress the pandemic.
Biden administration buys 100,000 doses of Lilly antibody drug
The Biden administration on Friday announced an agreement to purchase 100,000 doses of Eli Lilly’s monoclonal antibody cocktail that was recently authorized by the Food and Drug Administration.
The move will increase the available supply of one of the few proven treatments for people with COVID-19. The antibody drugs are authorized for use in patients who are at high risk of becoming seriously ill but are not yet hospitalized.
Under the agreement, the federal government will pay $210 million for the initial purchase of up to 100,000 treatment courses of the therapeutic, which is a combination of the drug bamlanivimab, which was authorized last November for high-risk Covid-19 patients, with a second drug known as etesevimab.
The agreement includes flexibility to purchase up to a total of 1.2 million doses through November, but how much of that is exercised will likely depend on the course of the pandemic over the next several months.
Difficult to get: The hope is with the additional supply of drugs, they will be more readily available to people who need them. But demand has also been lackluster. Supply was limited at first, and making sure the drug gets to patients is a complex undertaking. Since they are infusion drugs, antibodies need to be administered in the proper setting. The window to administer the drugs is small, and patients need a quick diagnosis.
The plus side: The drugs are free, but health care facilities may charge for the administration.
Evidence of the vaccine working is coming out of Israel: Israeli vaccination campaign leads to plunge in severe COVID-19 cases
A mass vaccination campaign in Israel that targeted older residents led to a steep drop-off in the number of coronavirus cases requiring patients to go on a ventilator, a hopeful sign as other nations ramp up vaccine access and distribution.
A new report published Friday in the U.S. Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report found the number of older patients in Israel requiring ventilation to treat COVID-19 plummeted beginning in the middle of January.
Before the vaccination campaign started, about six times as many patients over the age of 70 required ventilation to assist breathing as those under the age of 50. By the middle of February, when more than 8 in 10 older Israelis had been vaccinated, that ratio dropped to just a 2 to 1 margin.
The drop in the number of older patients who required ventilation began in mid-January, about the time the first people to receive a vaccine in Israel began getting their second doses.
“Considering the vaccination rate and the expected vaccine efficacy, this study provides preliminary evidence at the population level for the reduction in risk for severe COVID-19 as manifested by need for mechanical ventilation, after vaccination with the Pfizer-BioNTech Covid-19 vaccine,” CDC researchers wrote.
One dose of Pfizer vaccine offers significant protection for those who have had COVID-19: studies
Two new British studies published late Thursday found that a single dose of the Pfizer-BioNTech coronavirus vaccine may offer significant protection for people who have already been infected with COVID-19.
The studies, published in the weekly peer-reviewed medical journal The Lancet, provide further evidence for increased calls among experts to give only one dose to individuals that are already carrying antibodies against the virus.
“This could potentially accelerate vaccine rollout,” researchers at University College London and Public Health England said in one of the studies. “With increasing variants (UK, South Africa, Brazil), wider coverage without compromising vaccine-induced immunity could help reduce variant emergence.”
The University College and Public Health England researchers analyzed data among 51 health workers in London who have agreed to routine antibody and infection tests since March.
The researchers found that among roughly half of the workers who had been infected, a single dose of the Pfizer-BioNTech vaccine increased their antibody levels “more than 140-fold from peak pre-vaccine levels.”
Coming next: A CDC advisory committee will discuss the single dose possibility on Monday.
What we’re reading:
Andrew Cuomo’s Covid-19 nursing home fiasco shows the ethical perils of pandemic policymaking (Stat)
The Coronavirus is threatening a comeback. Here’s how to stop it (New York Times)
5 pandemic mistakes we keep repeating (The Atlantic)
State by state:
With GOP back at helm, Montana renews push to sniff out welfare fraud (Kaiser Health News)
Baker’s public safety secretary received a COVID-19 vaccine as ‘first-line responder’ (Boston Globe)
Are Bay Area vaccine sites giving out extra shots? (SF Gate)
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