Most Americans are unlikely to be vaccinated with a coronavirus vaccine until mid-next year, say U.S. officials and public health experts, even as the federal government urges states to prepare to distribute a vaccine as early as November.
U.S. health officials expect to know by the end of the year or sooner if at least one of the three potential vaccines from Moderna, Pfizer, and AstraZeneca will work in late-stage trials. Albert Bourla, Pfizer's CEO, said Thursday the company could get results from its late-stage coronavirus vaccine study as early as October.
Regardless of which vaccine gets regulatory approval from the Food and Drug Administration, it will likely run short once it's cleared for public distribution, officials and experts warn. The vaccine is likely to require two doses at different intervals, and states still face logistical challenges such as setting up distribution points and obtaining enough needles, syringes, and bottles needed for immunizations.
The Centers for Disease Control and Prevention is currently calling on states to speed up the approval process for medical utility McKesson so it can set up coronavirus vaccination sites in the US by Nov. 1. The agency said states may have to waive some licensing and licensing requirements that could block the process.
Still, a vaccine ready for public distribution in November is "extremely unlikely," said Dr. Moncef Slaoui, who heads the Trump administration's Operation War Speed initiative, in an interview with NPR released Thursday night.
"There is a very, very small chance that the trials that are currently underway could be ready before the end of October," he told NPR. "And so, if all the other conditions required for an emergency permit are met, there could be a permit. I think that is extremely unlikely but not impossible."
He said he "firmly" believes that a vaccine will be available before the end of the year and "in amounts that can immunize patients at highest risk, meaning the very old, 70 years and older, and possibly people which are strongly exposed the first line. "
Dr. Scott Gottlieb, a former FDA commissioner, said widespread use of a coronavirus vaccine in the US was likely "an event by 2021".
He said the vaccine will likely be approved by the FDA during periods where "incremental groups will have access to the vaccine by the end of this year, provided they work and they are shown to be safe and effective."
On Tuesday, the National Academies of Science, Engineering and Medicine released a draft proposal for the distribution of a vaccine in the United States, if one is approved for public use. The report was requested by the National Institutes of Health and the CDC.
The vaccine would be distributed in four phases, with health workers, the elderly, and people with underlying health conditions being vaccinated first, according to the group. Next on the list are key workers, teachers and people in shelters for the homeless and people in prisons, followed by children and young adults.
The CDC estimates that there are between 17 and 20 million healthcare workers in the US alone, nearly the entire number of vaccine doses the US expects by the end of the year, according to Slaoui. He told NPR the US should be able to immunize up to 25 million people by the end of the year.
He said the nation will "be able to immunize the US population by mid-2021".
Gottlieb was a little more optimistic about the timing during an interview on CNBC's "Squawk Box" on Friday. He said a vaccine will be widely available in the first quarter. "Maybe it's more like the first half of 2021 … but it will clearly slide by 2021."
Emergency clearance allows the FDA to "provide approval, access to the vaccine, to various high-risk groups while they continue to collect data," he said.
It also enables the FDA to collect a variety of data, post-market data, about a product's use and effectively identify what is a registry where they continue to collect safety and efficacy data on people while they are out are to be vaccinated. "
"In terms of the availability of a vaccine for widespread distribution where you can actually go to your doctor's office or distributor and get the vaccine … that's clearly a 2021 event," Gottlieb said.
The World Health Organization does not see widespread vaccinations until the middle of next year. The agency said the ongoing Phase 3 trials will take longer as scientists need to assess whether the vaccines are "truly protective".
"You also have to see how safe it is," said WHO spokeswoman Margaret Harris. "There are earlier stages where you study security and check security very, very carefully before you move into stage third. However, you need to follow security at all stages to make the process longer."
A key forecast predicts the U.S. will top more than 410,000 Covid-19 deaths by the end of the year as the country goes into fall and winter. This emerges from new forecasts by the Institute for Health Metrics and Evaluation at the University of Washington.
Covid-19 has already killed at least 186,800 people in the United States, according to Johns Hopkins University. IHME's model, whose models were previously cited by the White House and state officials, predicts the death toll will more than double by Jan. 1 and could reach 620,000 if states Aggressively easing coronavirus restrictions and disregarding public health guidelines.