Operation Warp Speed officials changed course on their vaccine rollout plans on Tuesday, widening recommendations for who should get COVID-19 shots and promising to send out more first doses, no longer reserving second shots.
The move by the Trump administration’s $18 billion vaccine development public–private partnership comes amid a disappointingly slow first month of nationwide vaccine distribution. The change will aim to maximize the number of people receiving the first of their two shots, offering some protection against a pandemic surging at unprecedented levels nationwide.
Vaccines will now be recommended for all people over the age of 65 or anyone with a high-risk condition, such as diabetes, heart disease, or obesity, a total population estimated to include roughly 109 million people.
The federal government will also start to assist states in setting up mass vaccination sites, Department of Health and Health and Human Services Chief Alex Azar said Tuesday.
“We need doses going to where they will be used most quickly,” said Azar. Allocations of vaccines starting in two weeks will be based on the size of each state’s over-65 population and will require them to report they have used the vaccines they have been given, he added. “Moving on to the broader population when vaccine supply met demand has always been part of the plan.”
In the last week alone, more than 1.7 million Americans have been diagnosed with COVID-19 and 22,582 have died, according to the CDC. The OWS changes come ahead of a Thursday briefing by President-elect Joe Biden, whose transition team last week announced similar plans to push out all available vaccine doses, part of a campaign pledge to give 100 million shots in the first 100 days of the Biden administration.
After initially aiming to have 300 million vaccine doses distributed by January, OWS steadily lowered its projections to 20 million by December, a target it also missed, with under 9 million people having received a first shot as of Monday. Vaccination rates are now roughly at 700,000 shots a day nationwide, according to OWS's Gen. Gus Perna, with hopes that will rise to 1 million a day in the next two weeks.
The FDA has authorized two vaccines, one made by Pfizer and the other by Moderna, for emergency use. Large-scale clinical trials found that the vaccines were highly protective against COVID-19 when given in two doses spaced three or four weeks apart. But over the holidays, facing a nationwide surge driven largely by a new extra-contagious coronavirus variant, the United Kingdom moved to expand the window for second doses of its authorized vaccines to as many as 12 weeks. Last week, a World Health Organization expert panel suggested a six-week window was acceptable.
A tense public debate has since played out over the risks of pushing ahead with giving just one shot to maximize the number of people who could be vaccinated in the US. Some fear that it could lead to partially immunized people getting infected and could enable the virus to develop resistance to the vaccines. On Tuesday, Azar stressed his belief that manufacturers would be able to produce enough doses to keep on schedule, and that getting people their second shots would still be a priority.
Lost in the debate is that, while some states like New York have struggled with a lack of vaccine supply, many others have been battling a lack of vaccinators to give the shots. Of more than 25 million shots sent out by OWS to thousands of locations in 64 jurisdictions nationwide, only about a third of those shots have been injected into people.
In Los Angeles, where hospitals are being crushed by a record influx of severely ill COVID-19 patients, Dodger Stadium, the largest testing site in the country, is being converted into a vaccination distribution center. California is currently ranked 46th nationwide in the number of doses they’ve administered per 100 people.
“I think this is the ultimate demonstration of problems with the American healthcare system, which is fragmented, which probably has the wrong priorities,” said University of Michigan epidemiologist Arnold Monto, the acting chair of the FDA’s vaccine advisory committee, speaking at a briefing held by the JAMA medical journal on Monday. “We totally underestimated the challenges that this would provide, because we're really not as organized as countries which have healthcare as a more systematic component of the government.”
On Tuesday, Azar said such backlogs would be factored into which states got additional doses. “If you are not using vaccines that you have, then we should rebalance to states that are,” Azar said. "Our states aren’t using 100% of their allocated vaccine.”
Part of the announcement included an expansion of federal partnerships with pharmacies to deliver shots, said Azar. Hospitals are not where most people go for vaccines, and moving to distribute shots to community pharmacies will help reach more people in lower-income and minority communities hit hardest by the pandemic, he suggested.
Infectious Diseases Society of America president Barbara Alexander called the new changes "an important step toward controlling the pandemic" in a statement on Tuesday evening, but stressed the need for more federal funding for staff, supplies and space for mass vaccinations. Efforts to accelerate vaccinations must emphasize minority communities hit disproportionately hard by the pandemic and sidelined in past immunization campaigns, she said. "Vaccines in arms save lives. Vaccines in storage do not."
This story has been updated with comment from the Infectious Diseases Society of America.