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Something to watch: Billionaire and “Shark Tank” host Mark Cuban is launching a new online pharmacy and promising some steep discounts on drugs.
The FDA also announced today it is halting the use of two monoclonal antibody treatments because they don’t work against the omicron variant.
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FDA limits use of two antibody treatments
The Food and Drug Administration (FDA) on Monday significantly restricted the use of a pair of monoclonal antibody treatments for COVID-19 because they are ineffective against the omicron.
The agency said the therapies made by Eli Lilly and Regeneron should only be used in patients who have been infected with or exposed to a variant that is susceptible to the treatments.
“Because data show these treatments are highly unlikely to be active against the omicron variant, which is circulating at a very high frequency throughout the United States, these treatments are not authorized for use in any U.S. states, territories, and jurisdictions at this time,” the FDA said.
The omicron variant began spreading across the U.S. in late November, and now accounts for more than 99 percent of infections, according to the Centers for Disease Control and Prevention.
As a result, the FDA noted that “it’s highly unlikely that COVID-19 patients seeking care in the U.S. at this time are infected with a variant other than omicron.”
Not revoked: However, the agency did not revoke the emergency authorization because regulators want to be able to use the drugs again if the situation arises.
“In the future, if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to these treatments, then use of these treatments may be authorized in these regions,” FDA said.
There are others: Hospitals and physicians have other options available. The antibody treatment now most recommended is sotrovimab, from GlaxoSmithKline and Vir Biotechnology. The administration will also continue to allocate doses of Pfizer’s antiviral drug Paxlovid, as well as one made by Merck called molnupiravir. However, both Paxlovid and sotrovimab are in short supply.
More antibodies present months after booster
A new study shows high levels of coronavirus antibodies that fight the omicron variant four months after a third dose of the Pfizer vaccine, a positive sign for the durability of a booster shot’s effectiveness.
The study from researchers at Pfizer, BioNTech and the University of Texas Medical Branch shows virus-fighting antibodies enduring four months after the third dose, helping answer the key question of how long protection from the booster shot lasts.
Eric Topol, professor of molecular medicine at Scripps Research, tweeted in response to the study that antibody levels were “unexpectedly still quite high” after four months, “which is great.”
Takeaway: The results add to a growing body of evidence on the importance of booster shots, which health officials are urging people to get in the face of a surge from the omicron variant.
Last week, a Centers for Disease Control and Prevention (CDC) study found that a third shot was 90 percent effective against hospitalization, compared to just 57 percent effectiveness against omicron for someone who is six months past their second shot.
Remaining question: There is still an open question as to how long protection from a booster shot will last beyond four months. That information would help inform whether and when a fourth shot might be needed.
Pfizer said Monday it would be evaluating “an additional dose of both the current formulation and an Omicron based vaccine,” going forward.
A ‘CRITICAL JUNCTURE’ IN THE PANDEMIC
The director-general of the World Health Organization (WHO) on Monday encouraged countries to work together to end the COVID-19 pandemic, saying that “we are at a critical juncture.”
“The COVID-19 pandemic is now entering its third year and we are at a critical juncture,” Tedros Adhanom Ghebreyesus said at a press conference, Reuters reports.
“We must work together to bring the acute phase of this pandemic to an end. We cannot let it continue to drag on, lurching between panic and neglect,” he added, noting that the tools to bring this phase of the pandemic to an end are available.
Last week, the agency said COVID-19 cases across six WHO regions grew by 20 percent, marking a slowdown from previous weeks.
However, the WHO warned that “despite a slowdown of the increase in case incidence at the global level, all regions reported an increase in the incidence of weekly cases with the exception of the African Region, which reported a 27 percent decrease.”
Virginia’s AG urges SCOTUS to overturn Roe
Virginia’s newly elected Republican attorney general has urged the Supreme Court to overrule Roe v. Wade and hand abortion authority over to the states, reversing the commonwealth’s legal position in a landmark challenge now pending before the court.
Under the state’s previously Democratic-led administration, Virginia joined 21 other states in urging the justices to invalidate Mississippi’s 15-week abortion ban and reaffirm the core holding of the court’s 1973 decision in Roe.
But in his first week on the job after defeating the state’s Democratic incumbent in a November election, Virginia’s new attorney general, Jason Miyares (R), announced a dramatic shift in course.
“The [new] Attorney General has reconsidered Virginia’s position in this case,” Miyares told the justices in a letter Friday. “Virginia is now of the view that the Constitution is silent on the question of abortion, and that it is therefore up to the people in the several states to determine the legal status and regulatory treatment of abortion.”
To watch for: Roe prohibits states from banning abortion before fetal viability, which occurs around 24 weeks. A decision over the fate of Mississippi’s 15-week ban, which directly clashes with Roe’s central holding and the nearly five decades of Supreme Court precedent upholding it, is expected by June.
During a tense hearing in the case last month, the justices seemed prepared to roll back the legal regime that emerged from Roe in a manner that may permit states to place new limits on abortion.
UNVACCINATED NOW BARRED FROM FRENCH RESTAURANTS, SPORTS VENUES
France on Monday started barring unvaccinated individuals from entering restaurants, bars, tourist sites and sports venues unless they recently recovered from a COVID-19 infection.
The country is now requiring that individuals ages 16 and older present a “vaccine pass” to enter a number of public establishments, according to The Associated Press. The country’s parliament and Constitutional Council approved the initiative last week.
The vaccine pass, however, cannot be required for entry at political rallies, according to France24.
The new initiative comes as the number of daily COVID-19 cases in France has surged to its highest level recorded throughout the pandemic, according to data compiled by The New York Times.
Patients with COVID-19 are still filling hospitals in France, but the number of individuals in the country’s intensive care units has decreased in recent days, according to the AP.
WHAT WE’RE READING
- US pharmacies are rolling out free N95 masks as free Covid-19 tests begin to arrive in the mail (CNN)
- More readily available than other COVID therapies, remdesivir now approved for outpatient use (MLive)
- They built a smarter approach to Covid clinical trials. Now they want to do the same for other diseases (Stat)
- As Covid-19 pills roll out, worry mounts that resistance could develop (Wall Street Journal)
STATE BY STATE
- Ga. voters will decide the next governor and the state’s status with Medicaid (NPR)
- Illinois governor announces COVID-19 sick leave initiative for vaccinated school staff (WAVY)
- More evidence points to decline in omicron surge, but hospitalizations remain high (Portland Press Herald)
- Anti-vaccination forces gear up for fight over California vaccine legislation (LA Times)
OP-EDS IN THE HILL
Let’s commit infrastructure funding to help older Americans lead healthier lives
That’s it for today, thanks for reading. Check out The Hill’s health care page for the latest news and coverage. See you Tuesday.