With the final hurdles surrounding new booster shots of the COVID vaccine have yet to be cleared, Chicago is already preparing for distribution of the omicron-specific doses starting as early as next week.
The Food and Drug Administration on Wednesday authorized the new shots aimed at targeting the omicron variant and the now-dominant BA.5 subvariant and an influential Centers for Disease Control and Prevention panel is expected to vote on recommendations for who should be eligible as early as Thursday. After that, the CDC has to give its own recommendations before shots can begin.
"Coming soon after Labor Day, updated COVID-19 vaccines and these new, what are called bivalent boosters as you may know already, are targeted specifically toward the omicron subvariants, the BA.4 and the BA.5 that are what are circulating right now," said Chicago Department of Public Health Commissioner Dr. Allison Arwady. "It's the first time we've had an updated COVID vaccine since the vaccine rollout."
Until now, COVID-19 vaccines have targeted the original coronavirus strain, even as wildly different mutants emerged. The new U.S. boosters are combination, or “bivalent,” shots. They contain half that original vaccine recipe and half protection against the newest omicron versions, called BA.4 and BA.5, that are considered the most contagious yet.
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The combination aims to increase cross-protection against multiple variants.
While answers to some questions, including those of eligibility and when you should get the new booster dose are likely to be answered by the CDC recommendations still to come, Arwady said the city expects to begin administering shots early next week following the holiday.
"So this vaccination really could, and I expect it probably will, begin next week, like right after Labor Day most likely," she said during a press conference discussing the city's plans Thursday. "It's really different from the boosters that have previously been offered. And I want you to understand that this vaccine gives us a chance to try and get ahead of the virus that helps us protect individuals from the variant that is currently circulating in the U.S."
Chicago has been given 150,000 doses of the updated vaccine from the federal government, which are expected to begin shipping in the first week.
"So we're expecting those 150,000 doses to go pretty wide," Arwady said, noting that city pharmacies are expected to receive vaccine within that first week, including Walgreens and CVS, though the city plans to prioritize at-risk groups in congregate settings and long-term care facilities and offer at least one vaccine location in every Chicago ward.
CVS told NBC 5 that, once the vaccine receives its final approval, it expects to begin receiving supply "on a rolling basis over the next few days."
Walgreens said it plans to offer updated boosters "at select locations" and highly encourages appointments, following CDC recommendations.
The move by the FDA tweaks the recipe of shots made by Pfizer and rival Moderna that already have saved millions of lives just ahead of the Labor Day holiday weekend. The hope is that the modified boosters will blunt yet another winter surge.
“It really provides the broadest opportunity for protection,” Pfizer vaccine chief Annaliesa Anderson told the AP.
"I don't have a crystal ball and can't completely predict what is coming. But I will tell you that both of the last two winters we've had notable COVID surges during respiratory virus season, during flu season, during, you know, RSV, other seasons. We also, as people, I think have relaxed against COVID. There's less mask-wearing happening broadly... in my ideal world, we would not see a significant surge, but I would be shocked if we did not see at least some surge in COVID infections as we move inside in the fall and winter and that the timing of that is likely to parallel what we see for flu."
Since July 2, the BA.5 omicron subvariant has been the dominant strain of COVID in the United States and in the Chicago area.
FDA vaccine chief Dr. Peter Marks said last week that once authorized, the tweaked boosters could help right away — while BA.5 infections still are too high — as well as hopefully blunt yet another winter surge.
Marks told the Associated Press that the new boosters could rev up the immune system to prevent not just serious illness but maybe milder infections, too, like the original vaccines did earlier in the pandemic, before super-contagious mutants emerged.
“The hope here is that by better matching things, not only will we get that benefit or even more, but we'll also have that last for a longer period of time,” he said.
But Dr. Paul Offit, a vaccine expert at the Children’s Hospital of Philadelphia and an FDA vaccine adviser, said the antibody jump from that earlier BA.1-tweaked candidate was “underwhelming.”
“What the administration is asking us to do is to accept this bivalent vaccine as significantly better” than another dose of today’s vaccine, he said. “It would be nice if there were data to support that.”
Arwady said the fact that BA.5 continues to be the dominant variant could play a role in preventing spikes in fall and winter cases, but that will depend largely on how many people get the vaccine.
"I worry about the healthcare system the most in the winter. So I can't completely predict what it'll look like, but getting this updated vaccine now in September and October, will be the best thing to help keep that surge as in control as we possibly can in November and December," she said. "And if people think that it's better, you know, to wait for a surge and then get the vaccine - that is definitely not true, based on everything we know now."
She added that fall tweaks to the vaccine could become a yearly process, much like the flu.
Still, the original vaccines offer strong protection against severe disease and death from COVID-19 for most generally healthy people, especially if they got that important first booster dose. It’s not yet clear just how much more benefit an updated booster will bring.
Part of the reason for the uncertainty is that the FDA cleared the modifications ahead of studies in people, a step toward eventually handling COVID-19 vaccine updates more like yearly flu shots.
First, FDA checked human studies of earlier Pfizer and Moderna attempts to update their vaccines — shots matching the omicron strain that struck last winter. That recipe change was safe, and substantially boosted antibodies targeting the earlier variant — better than another dose of the original vaccine — while adding a little protection against today's genetically distinct BA.4 and BA.5 omicron versions.
But FDA ordered the companies to brew even more up-to-date doses that target those newest omicron mutants instead, sparking a race to roll out shots in less than three months. Rather than waiting a few more months for additional human studies of that recipe tweak, Marks said animal tests showed the latest update spurs “a very good immune response.”
The hope, he said, is that a vaccine matched to currently spreading variants might do a better job fighting infection, not just serious illness, at least for a while.
"There will certainly be all of the monitoring and I'm actually really interested to see the efficacy of this for BA.4 and [BA.5] in particular - I expect it will be good," Arwady said. "And there are, if you look at all of the advisory groups, the experts - there's not any safety concerns related to the release of this. It's more a question of the efficacy."
The updated boosters are only for people who have already had their primary vaccinations, using the original vaccines. Doses made by Pfizer and its partner BioNTech are for anyone 12 and older while Moderna's updated shots are for adults — if it has been at least two months since their last primary vaccination or their latest booster. They're not to be used for initial vaccinations.
The U.S. has purchased more than 170 million doses from the two companies. Pfizer said it could ship up to 15 million of those doses by the end of next week.