As US COVID-19 cases surge even higher, with daily deaths passing the 2,000 mark for the first time since May, Pfizer and Germany’s BioNTech announced they submitted an emergency use authorization (EUA) request for their vaccine, offering hope that the first doses will be available by the end of the year.
And as the world passed 57 million cases, the World Health Organization (WHO) today recommended against using remdesivir for hospitalized patients.
Pfizer and BioNTech apply for EUA
In their announcement today, the Pfizer and BioNTech said the EUA request to the Food and Drug Administration (FDA) for their mRNA vaccine candidate could mean it will be available for high-risk populations by the middle to end of December. The new development comes just days after the companies announced final efficacy data for the vaccine, which suggests that protection is very high, even in seniors, and has a good safety profile.
The companies have submitted similar applications to European regulatory agencies and plans to submit others in the coming days. Through Operation Warp Speed (OWS), the US government has an agreement with the companies to purchase 100 million doses, and OWS officials have said they are prepared to begin distributing it within 24 hours of a granted EUA.
As part of next steps, the FDA’s independent advisory group, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will review company data, which will include a public meeting—likely in December—in which the companies will present their data. CDC vaccine advisors, the Advisory Committee on Immunization Practices (ACIP), typically make recommendations on issues such as priority groups, and their next meeting is on Nov 23, with COVID-19 vaccines slated as the main agenda item.
The head of the Infectious Diseases Society of America, Barbara Alexander, MD, said in a statement today that the group welcomes the possibility of a critical new tool against the pandemic. She said that a positive recommendation from the VRBPAC should be required before granting authorization and that its distribution should be informed by ACIP.
She added that once the EUA is granted, clinical trials need to continue, as well as other measures to curb the spread of the virus, including wearing masks, washing hands, and physical distancing.
Another sharp rise in US cases
Yesterday the United States reported 187,833 new cases and 2,015 deaths, according to the Johns Hopkins online dashboard. The fatality count is sharply higher than the 1,500 daily deaths that doctors on the White House coronavirus task force said the country might average next week, unless further steps were taken.
The number of Americans currently hospitalized is at 80,698, up from 79,000 yesterday, according to the COVID Tracking Project.
More states issued new restrictions to curb their rapidly growing case numbers, including Rhode Island, New Hampshire, and Maine, the Wall Street Journal reported. New Hampshire issued a statewide mask mandate, Maine ordered a curfew for some businesses, and Rhode Island ordered new limits on gatherings and announced a 2-week pause on certain educational and entertainment businesses.
New York officials signaled that the region is experiencing a second wave and that further restrictions in New York City might be coming soon, the New York Times reported. And in California, Gov. Gavin Newsom yesterday ordered a 10:00 pm to 5:00 am curfew for 41 of the state’s 58 counties that lasts until Dec 21, NPR reported.
President-elect Joe Biden said yesterday during a virtual meeting with governors that he wouldn’t implement a national shutdown, The Hill reported, and during a White House Coronavirus Task Force briefing yesterday, Vice President Mike Pence said no national shutdown would be ordered under the Trump administration.
In other US developments:
- An investigation into the impact of the 10-day Sturgis, SD, motorcycle in August on resident in neighboring Minnesota found 51 event-related cases, 21 secondary cases, and 5 tertiary cases, authors from Minnesota and their Centers for Disease Control and Prevention (CDC) partners wrote in Morbidity and Mortality Weekly Report They found 9 other cases that were likely linked to the rally. Four patients were hospitalized, and one death was reported. The team used genetic sequencing to confirm links between the cases.
- The US total today climbed to 11,854,203 cases and 253,882 deaths, according to the Johns Hopkins online tracker.
WHO weighs in on remdesivir
The WHO today issued a conditional recommendation against the use of the antiviral drug remdesivir for treating hospitalized COVID-19 patients, regardless of severity, because it says there is no evidence that it improves survival or other outcomes.
The recommendation comes from a clinical guideline group that looked at data from the WHO-led Solidarity Trial, which in the middle of October published interim findings in a preprint journal that found no clear benefit.
The move signals a clash about clinical use of the drug, given that the FDA approved the drug on Oct 22 for treating hospitalized patients. Gilead, the maker of the drug, has said the Solidarity Trial results are inconsistent with what it said are more robust findings from other randomized controlled trials.
At a WHO media briefing today, officials said final Solidary Trial results will appear soon in a peer-reviewed medical journal, but that most of the data will be the same.
In other global developments:
- In Europe, the United Kingdom—now in its second lockdown—is reporting early signs of flattening its curve, but cases in Europe remain at very high levels, with Russia and Germany reporting new record single-day case totals.
- India’s total today topped 9 million cases, and a surge in New Delhi continues, averaging about 6,700 cases a day with intensive care units near capacity, the Associated Press reported.
- South Korea’s cases have been above 300 for 3 days in a row, and health officials are warning citizens that new restrictions will be needed if they don’t follow the ones that are already in place.
- Canada’s COVID-19 activity continues to accelerate, and the country’s modeling projections suggest that daily cases could reach 20,000 a day by the end of December, Reuters reported. Doctors in Manitoba, which recently imposed strict new measures, say hospitals are reaching capacity, and Ontario officials signaled that they may order another lockdown.
- The global total today reached 57,365,049 cases, and 1,368,746 people have died from their infections, according to the Johns Hopkins dashboard.