FDA prepares to OK a second vaccine as Covid-19 deaths top 40,000 this month
The Food and Drug Administration says it is “rapidly” working toward issuing an emergency use authorization for the Moderna vaccine — the second Covid-19 vaccine for the US market — after its vaccine advisers voted to recommend it.
The announcement comes nearly a week after the agency authorized Pfizer and BioNTech’s vaccine and amid a scary time for the country, as infection numbers, hospitalizations and daily death tolls continue to shatter records. Experts warn that in the coming weeks — especially if Americans opt to gather and travel for the holidays — things could get worse. And an ensemble forecast published Thursday by the Centers for Disease Control and Prevention projects there could be another 80,000 Covid-19 deaths across the US over the next three weeks.
In expectation that the FDA will soon give the green light, vaccine advisers to the CDC scheduled meetings for Saturday and Sunday to discuss the Moderna vaccine. The group must vote to recommend the vaccine and the CDC must accept that recommendation before vaccinations can begin.
“I think this is a very exciting moment,” Dr. Hayley Gans, a member of the FDA’s vaccine advisory committee, told CNN. “The data that was presented to us was striking in its efficacy.”
Here’s how Moderna’s vaccine differs from Pfizer’s
If the Moderna vaccine is authorized, officials expect another 7.9 million vaccine doses to be shipped to states next week, Adm. Brett Giroir, assistant secretary for health at the Department of Health and Human Services, said. Earlier this week, HHS Secretary Alex Azar said two million doses of Pfizer’s vaccine and 5.9 million doses of Moderna’s had been allocated for next week.
“We still anticipate that every American will have the opportunity to be vaccinated by June,” Giroir said.
The task at hand now is to tackle skepticism many communities have toward the vaccine, and pass along the facts, according to Dr. Francis Collins, the director of the National Institutes of Health.
“I’ve had the chance to be intimately involved in every step of the way here in the development of these vaccines. There have been no shortcuts taken, there’s no hidden information,” he told CNN. “This is something you want to do, for yourself, for your family, for the future of our nation.”
“Because if we don’t get to that point of 70 to 80% of Americans being immunized, this could go on and on and on and we could lose even more lives, and that would be the worst possible kind of tragedy,” he added.
Some states see Covid-19 numbers surge, others loosen restrictions
On Thursday, the country reported more than 230,000 new cases and more than 3,200 deaths. This month alone, the US has reported more than 42,000 Covid-19 deaths.
Hospitalizations also continue to creep upward, with now more than 114,200 Covid-19 patients nationwide, according to the COVID Tracking Project.
Florida reported the highest number of daily new cases since mid-July. Kentucky’s governor announced a record number of new deaths, saying it was “by far the most people that we’ve lost.” Pennsylvania’s health officials announced the state’s number of hospitalizations is double the peak in the spring, with more than 1,200 Covid-19 patients in the ICU.
“We continue to hear of additional hospitals across the state that have few ICU beds left, or in some cases no ICU beds left,” Secretary of Health Dr. Rachel Levine said Thursday.
Hospitalizations are also up in New York City, the mayor announced, while the average of new cases is a number that “just keeps getting bigger and bigger.” And in Oregon, Gov. Kate Brown said hospitals remain “stretched to their limits” and extended her declaration of a state of emergency for Covid-19 for another two months, adding “these are the darkest days of this pandemic.”
But while many states are still battling a ferocious spread, others are loosening restrictions.
Iowa Gov. Kim Reynolds said this week that Covid-19 case numbers have gone down in the state, and announced she was lifting all curfews for bars and restaurants and removing limitations for social gatherings.
Bars and restaurants will be able to resume normal operations as long as customers are seated when eating or drinking, wear masks when not seated, be seated six feet away from other groups and there are no more than eight people per group, the governor said. The governor also announced she was lifting gathering limitations, but a distance of six feet is required between groups.
In Utah, where health officials said hospitals across the state are operating at capacity, Gov. Gary Herbert announced he was removing the restriction on alcohol sales after 10 p.m., saying local bars and restaurants have demonstrated a willingness to enforce physical distancing and mask wearing when customers aren’t eating or drinking.
“We appreciate the willingness to step up and help enforce protocols that make bars and restaurants a safe environment for the patron to come and participate,” the governor said.
‘Another couple of dark months ahead of us’
While the country waits for the vaccine impacts to really kick in — something that won’t likely happen until the early summertime, when vaccines will become more widely available — the tools that could immediately work to help curb the spread of the virus are the ones that have been touted by experts for months: face masks, social distancing, and regular hand washing.
“You don’t want to just say, ‘Oh well, we’re almost there,’ because we’re not. We have another couple of dark months ahead of us if we don’t do something at this point to try to stop this dreadful upward curve of hospitalizations and cases and deaths.”
“This is not the moment to be throwing down your guard and gathering for the holidays,” he added.
State leaders have echoed the warning in recent days, urging residents to reconsider their holiday plans.
In Wisconsin, a state that’s been hit especially hard since the start of the fall surge, Gov. Tony Evers urged residents to celebrate virtually, adding hospitals remain “strained” and continue to report staffing shortages.
In California, one county health official called the climbing Covid-19 numbers a “post-holiday surge that doesn’t need to be.”
“This is a lot of intermingling that needn’t have happened, but it did happen, and it created for us an enormous increase in our cases,” Los Angeles County Public Health Director Barbara Ferrer said.
“We’re going into a new holiday season. We really need people to stay home. Not mingle, not travel.”
In Tennessee, Gov. Bill Lee said that while authorization of vaccines is an important turning point in the pandemic, the sobering reality was that more residents are getting sicker and the decisions people made over the Thanksgiving holiday is having a severe impact on the state’s hospital system.
“One thing this vaccine will not solve or cure, is selfishness or indifference to what is happening to our neighbors around us,” he said.
Some states will receive fewer vaccine doses
Multiple states — including Iowa, Illinois, Washington, Michigan and Oregon — have now also been told by the federal government to expect fewer doses of Pfizer’s vaccine than initially promised.
On Thursday, Washington Gov. Jay Inslee wrote on Twitter he was informed the state’s vaccine allocation “will be cut by 40% next week,” and added “no explanation was given.”
“This is disruptive and frustrating,” he wrote. “We need accurate, predictable numbers to plan and ensure on-the-ground success.”
The cause of the delay remains unclear to many. An HHS spokesperson said reports of jurisdictions’ allocations being reduced are “incorrect” and that overall states will receive their full supplies — though deliveries may be spread out over a longer time frame.
“As was done with the initial shipments of Pfizer vaccine, jurisdictions will receive vaccine at different sites over several days. This eases the burden on the jurisdictions and spreads the workload across multiple days. This same process was successfully used for the initial distribution of Pfizer’s vaccine, and we are simply applying lessons learned,” the spokesperson said.
Pfizer said in a Thursday statement that the company was “not having any production issues” and that “no shipments containing the vaccine are on hold or delayed.”
“We have millions more doses sitting in our warehouse but, as of now, we have not received any shipment instructions for additional doses,” Pfizer said.
