The Food and Drug Administration’s panel of vaccine advisers on Thursday gave the green light for federal regulators to grant Moderna’s vaccine emergency use authorization, setting the government up for another massive vaccine distribution program.
The final vote was 20-0, with one abstention.
During the daylong meeting, streamed online for public access, Moderna executives and members of the Vaccines and Related Biological Products Advisory Committee answered questions from public health experts and epidemiologists. The extensive range of topics discussed included the severity of side effects and the company’s plan to offer placebo recipients the vaccine, a move that the FDA panelists cautioned would limit the quality of the data about the vaccine’s long-term efficacy and side effects.
Members also called for the continued investigation into potentially fatal side effects, particularly in people of color who get the shots. The vaccine trial’s pool of volunteers was 79.2% white, and the average age of participants was 51. Dr. Rachel Zhang, the FDA’s medical officer, assured panelists that “efficacy outcomes were consistently greater than 93% across demographic subgroups.”
Jacqueline Miller, senior vice president of infectious disease development at Moderna, also said, “Our view is actually that the efficacy in the elderly is, indeed, consistent with the efficacy in the overall population.”
Moderna will continue monitoring the vaccine’s performance in the months to come to track new and potentially severe side effects. Clinical trial results showed side effects were mostly mild, including chills, pain at the injection site, and fatigue.
“We have a setup for distribution of vaccine under EUA,” said Doran Fink, deputy director of the FDA’s Division of Vaccines and Related Products Applications. “We’ll be monitoring the [intensive safety surveillance system] closely. If we detect any signals, we will investigate those rapidly. If we conclude that there is a need to inform vaccine providers … or the general public about a risk that has not been previously appreciated, we will do so.”
The agency had already concluded on Tuesday that Moderna’s vaccine is “highly effective in preventing … COVID-19.” This finding, coupled with the vaccine panel’s endorsement, has set the Moderna vaccine up for a speedy authorization.
The pandemic may be inducing couples to get engaged at higher rates. Jamie Singleton, the president of the Kay, Zales, and Peoples jewelry retailers, said that in the third quarter of the year, the three brands saw “double-digit” percentage growth in engagement ring sales as compared to the same period in 2019, the Washington Post reported. She expects the traditional “engagement season” between Thanksgiving and Dec. 31, when Singleton said one-half of annual proposals usually take place, will also bring bigger sales than usual. “What we’re learning is that the people that we quarantine with, for the most part, have become the nucleuses of [our] lives,” she said.
The availability of ICU beds in Southern California hospitals has hit 0%, the Los Angeles Times reported. When an intensive care unit hits 0% capacity, hospital staff place patients in open beds in the emergency department. However, without medical professionals who have been specially trained to work in the ICU, mortality rates could rise and the quality of care could deteriorate. The 0% figure reflects how much of the hospital’s typical ICU capacity remains but does not mean that the hospitals have no ICU beds left. When ICU capacity hits 0%, the hospital goes into surge mode, which can accommodate 20% over its usual capacity.
Tennessee hospitals have been inundated with COVID-19 patients, and healthcare providers are struggling to find alternate facilities in neighboring states to transfer patients they can’t admit, according to the Associated Press. Tennessee hospitals admitted an average of 2,959 new patients per day over the past week, and the rate of new hospitalizations has shown no signs of slowing, according to the COVID Tracking Project.
“We’ve now had to look at sending people home with oxygen instead of admitting them to the hospital because we don’t have anywhere to put these patients, unfortunately,” Dr. Laura Lyons, an emergency room physician in Sumner County, said Wednesday.
To date, more than 17.1 million cases and nearly 310,000 deaths due to COVID-19 have been confirmed in the United States. Current case totals are undercounts, given that many infections go undetected and undiagnosed.
French President Emmanuel Macron has contracted COVID-19 and will be in quarantine for a week. His office announced that the president will carry on with his duties from his home “in accordance with current health regulations applicable to all.”
While it is unclear how Macron contracted the virus, he attended several high-level meetings over the past few days, including some with other world leaders, CNN reported.
Rhode Island Gov. Gina Raimondo was seen at a public wine and painting event without a mask last Friday after urging people in her state to abide by COVID-19 restrictions and stay home. Raimondo’s office did not immediately respond to a request for comment from the Washington Examiner but told another outlet, “The governor had dinner at a local restaurant with her husband, and had her mask on anytime she was not eating/drinking.”
Gov. Jared Polis’s administration this week released its “roadmap to in-person learning,” proposing such strategies as on-site testing for those who are symptomatic and adding additional staff to help when school staff must quarantine are among the road map’s recommendations.
“Protecting in-person learning means creating a safe environment for educators and students, an accessible and transparent process for information sharing, and fostering accountability among all parties involved,” the road map concludes.
Don’t expect the coronavirus pandemic to end anytime soon, U.S. and international public health officials say, despite the nascent vaccine rollout.
“These vaccines are not a silver bullet that will end the pandemic in the near future,” the World Health Organization’s Takeshi Kasai, the agency’s lead official for the Western Pacific, told reporters.
Illinois’s next two shipments of the Pfizer vaccine aren’t going to be as big as expected.
During his daily briefing Wednesday, Gov. J.B. Pritzker said Illinois would not be getting the anticipated 8 to 9 million doses as initially planned.
“This development will likely cut our state’s projected Pfizer shipments this month by roughly half, the same is true across the rest of the nation,” said Pritzker.
The next two shipments will be closer to 4.3 million doses. No reason was given for the reduction.
A Georgia college student and her boyfriend are facing four months behind bars after violating strict COVID-19 quarantine restrictions in the Cayman Islands.
Skylar Mack, 18, arrived in the Cayman Islands on Nov. 27 and was required to quarantine for two weeks before interacting with others in the country, but two days after arriving, she snuck out to see her 24-year-old boyfriend Vanjae Ramgeet, a resident of the Cayman Islands and professional watercraft racer, compete in a Jet Ski event.
Both she and Ramgeet are accused of interacting with others at the event for about seven hours while not practicing social distancing or wearing masks, according to People. Mack was later detained at the scene of the contest, which Ramgeet won.
The two pleaded guilty to the offense and were initially sentenced to 40 hours of community service and a $2,600 fine, although the Office of the Director of Public Prosecutions appealed the sentence, claiming it was too lenient. The judge, Grand Court Justice Roger Chapple, agreed and increased the sentence to four months in jail on Tuesday.
The opioid epidemic has gotten worse during the COVID-19 pandemic, according to new data released by the Centers for Disease Control and Prevention Thursday.
The CDC reported Thursday that, based on provisional data, over 81,000 drug overdose deaths occurred in the U.S. in the 12 months ending in May 2020. That is the largest number of opioid deaths in a 12-month span.
Deaths due to synthetic opioids jumped 38.4%, the largest increase of any drug. Deaths from cocaine increased 26.5%.
The CDC said that overdose deaths were increasing prior to the pandemic but added that “the latest numbers suggest an acceleration of overdose deaths during the pandemic.”
