COVID-19 vaccines near end of clinical trials, but distribution still a way off

Last Wednesday, Dr. Robert Redfield, head of the Centers for Disease Control and Prevention, released a 57-page playbook detailing what the national vaccine program might look like once the Food and Drug Administration approves a safe, effective COVID-19 vaccine.
The report was released after conflicting statements about when a vaccine would be publicly available. President Donald Trump incorrectly claimed that a vaccine would be available within the next three to four weeks, but Redfield quickly corrected him saying the general public would most likely not have access to a vaccine until the middle of 2021.
There are currently three companies with vaccines in late-stage clinical trials in the U.S.: Pfizer, Moderna and AstraZeneca. All three are saying they hope for results before the end of the year, which would allow the FDA to approve their vaccines for public use, according to reporting from the New York Times.
But the end of clinical trials and approval from the FDA would just be the start of the long and complicated process of mass-producing a potential vaccine and distributing it across the country.
The most recent CDC report outlines a three-phased plan for the distribution of a vaccine. The first stage would prioritize healthcare personnel working with COVID-19 patients, people with an increased risk of severe illness like elders and the immunocompromised, and other essential workers with a high risk of infection.
The second phase would finish vaccinating essential workers and begin distribution to the general public while the vaccine is still in limited supply.
The third phase would occur when there is a surplus of the vaccine, and finish vaccinating any populations that were not reached by the first two phases.
FDA approval, mass production and distribution will all take time, and it will be months from when a vaccine is finished with clinical trials to when it is available to the public, according to expert testimony cited by the New York Times and the Poynter Institute.
Most vaccines in development also require a second doses 21 to 28 days after the first one, according to the CDC report, meaning that even after a vaccine is produced and widely distributed, the immunization of whole populations will be a multi-month process.
Norton Sound Health Corporation Medical Director Dr. Mark Peterson said that the state of Alaska and Alaska Native Medical Center are advising NSHC to be ready to receive a vaccine by November or December, although January or February are more likely.
“We know that getting a large supply to vaccinate the whole region is going to be significantly later than that,” he added. He said a COVID-19 vaccine would be available to the general public, in an optimistic scenario, around the middle of 2021.
“For a flu vaccine, we get a good chunk of people vaccinated over the course of six to eight weeks,” he said. “It takes time to get it out to people, it’s not like we get it this week and get it to everybody next week.”
That distribution time, coupled with the multiple weeks it takes between doses for each patient, will mean a public immunization will be reached much later than the optimistic end-of-year predictions for the end of clinical trials, he said.
He also said the easing of restrictions like quarantine mandates, mask-wearing and social distancing would likely not come at the exact same time as a vaccine. Any vaccine approved by the FDA will be at least partially effective, but it may not be a “silver bullet.”
Instead, it’s more likely that a combination of vaccination, treatment and a general reduction in case numbers would allow for the slow rollback of restrictions. “I think it’s going to be gradual,” Dr. Peterson said.
As far as the safety of a vaccine, he expressed confidence in the FDA’s strict safety requirements. While he could not vouch for the experimental treatments already available in Russia and China, he said any vaccine approved in the U.S. would be safe.
“I’m going to reassure everybody that if a vaccine is approved for use in the United States, people should be standing in line to get it,” he said. “Because I certainly will be, and our healthcare providers certainly will be.”
He also said he wasn’t sure if there would be a delay in getting the vaccine out to Nome and the surrounding villages because of the region’s remoteness. “We haven’t gotten any word that it’s going to be delayed here,” he said. “We certainly have our politicians working hard on that.”
In the meantime, NSHC is rolling out a large flu vaccination campaign as “a dress rehearsal for a COVID-19 vaccination campaign,” according to Gary Kulka, an NSHC doctor who outlined the region’s flu vaccination efforts on a conference call.
NSHC is aiming to vaccinate 60 percent of the region for the flu this year, up from the 40 percent they usually aim for, both to prepare for a COVID-19 vaccination and prevent the flu from spreading as much as possible, since respiratory problems from the flu and COVID-19 can compound each other and be more dangerous than either disease is on its own.
The locations of flu clinics in Nome should be announced this week, Kulka said, and begin dispensing vaccine soon after. During the end of September and beginning of October, travelling teams will go to the villages and administer vaccine there as well, aiming to finish by the middle of October.
Dr. Peterson said he wanted to stay optimistic as the COVID-19 vaccine situation continues to develop. “We want to keep people’s spirits up, we want to let them know there’s a light at the end of the tunnel,” he said.
He hopes the upcoming light could be an effective vaccine that’s approved before the end of the year, which appears to be a distinct possibility, although not a given. Problems with clinical trials, FDA approval, manufacturing and distribution could all cause the timeline to be delayed, and as of now there is no straightforward way to predict when a vaccine will take effect.

 Funding for this coverage provided in part by a grant from the Alaska Center for Excellence in Journalism.

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