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New COVID-19 vaccine boosters, targeting new Omicron strains of the virus, are expected to roll out across the US in September — a month ahead of schedule, the Biden administration announced this week.
Moderna has signed a $1.74 billion federal contract to supply 66 million initial doses of the "bivalent" booster, which includes the original "ancestral" virus strain and elements of the Omicron BA.4 and BA.5 variants. The government also chose to order 4 million doses for children, bringing the total contract to $1.8 billion. Pfizer also announced a $3.2 billion US agreement for another 105 million shots. Both vaccine suppliers have signed options to provide millions more boosters in the months ahead.
About 83.5% of Americans have received at least one COVID-19 shot, with 71.5% fully vaccinated with the initial series, 48% receiving one booster shot, and 31% two boosters, according to the CDC. With about 130,000 new COVID cases per day, and about 440 deaths, officials say the updated boosters may help rein in those figures by targeting the highly transmissible and widely circulating Omicron strains.
Federal health officials are still hammering out details of guidelines and recommendations of who should get the boosters, which are expected to come from the CDC and FDA. For now, authorities have decided not to expand eligibility for second boosters of the existing vaccines — now recommended only for adults over 50 and those 12 and older with immune deficiencies. Children 5 through 11 are advised to receive a single booster, 5 months after their initial vaccine series.
For a preview of what to expect from the CDC and FDA, we spoke with Keri Althoff, PhD, an epidemiologist at the Johns Hopkins Bloomberg School of Public Health. Excerpts of that interview follow.
Q: Based on what we know now, who should be getting one of these new bivalent boosters?
A: Of course, there is a process here regarding the specific recommendations, but it appears there will likely be a recommendation for all individuals to get this bivalent booster, similar to the first booster. And there will likely be a recommended time frame as to time since the last booster.
Right now, we have a recommendation for adults over the age of 50 or adults who are at higher risk for severe COVID-related illness [to get] a second booster. For them, there will probably be a timeline that says you should get the booster if you're X amount of months or more from your second booster; or X amount of months or more from your first booster, if you've only had one.
Q: What about pregnant women or those being treated for chronic health conditions?
A: I would imagine that once this bivalent booster becomes available, it will be recommended for all adults.
Q: And for children?
A: That's a good question. It's something I have been digging into, [and] I think parents are really interested in this. Most kids, 5 and above, are supposed to be boosted with one shot right now, if they're X amount of days from their primary vaccine series. Of course those 6 months to 4.99 years are not yet eligible [for boosters].
As a parent, I would love to see my children become eligible for the bivalent booster. It would be great if these boosters are conveying some additional protection that the kids could get access to before we send them off to school this fall.
Q: If you never received a booster, but only the preliminary vaccine series, do you need to get those earlier boosters before having the new bivalent booster shot?
A: I don't think they will likely make that a requirement — to restrict the bivalent booster only to those who are already boosted or up to date on their vaccines at the time the bivalent booster becomes available. But that will be up to the [CDC] vaccine recommendation committee to decide.
Q: Are there any new risks associated with these boosters, since they were developed so rapidly?
A: No. We continue to monitor this technology, and with all the mRNA vaccines that have been delivered, you have seen all that monitoring play out with the detection, for example, of different forms of inflammation of the heart tissue and who that may impact. So, those monitoring systems work, and they work really, really well, so we can detect those things. And we know these vaccines are definitely safe.A: No. We continue to monitor this technology, and with all the mRNA vaccines that have been delivered, you have seen all that monitoring play out with the detection, for example, of different forms of inflammation of the heart tissue and who that may impact. So, those monitoring systems work, and they work really, really well, so we can detect those things. And we know these vaccines are definitely safe.
Q: Some health experts are concerned "vaccine fatigue" will have an impact on the booster campaign. What's your take?
A: We have seen this fatigue in the proportion of individuals who are boosted with a first booster and even boosted with a second. But having those earlier boosters along with this new bivalent booster is important, because essentially, what we're doing is really priming the immune system.
We're trying to expedite the process of getting people's immune system up to speed so that when the virus comes our way — as we know it will, because [of] these Omicron strains that are highly infectious and really whipping through our communities — we're able to get the highest level of population immunity, you don't end up in the hospital.
Q: What other challenges do you see in persuading Americans to get another round of boosters?
A: One of the things that I've been hearing a lot, which I get very nervous about, is people saying, "Oh, I got fully vaccinated, I did or did not get the booster, and I had COVID anyway and it was really nothing, it didn't feel like much to me, and so I'm not going to be boosted anymore." We are not in a place quite yet where those guidelines are being rolled back in any way, shape, or form. We still have highly vulnerable people to severe disease and death in our communities, and we're seeing hundreds of deaths every day.
There are consequences, even if it isn't in severity of disease, meaning hospitalization and death. And let's not let the actual quality of the vaccine being so successful that it can keep you out of the hospital. Don't mistake that for, "I don't need another one."
Q: Unlike the flu shot, which is reformulated each year to match circulating strains, the new COVID boosters offer protection against older strains as well as the newer ones. Why?
A: It's all about creating a broader immune response in individuals so that as more strains emerge, which they likely will, we can create a broader population immune response [to all strains]. Our individual bodies are seeing differences in these strains through vaccination that helps everyone stay healthy.
Q: There haven't been clinical trials of these new mRNA boosters. How strong is the evidence that they will be effective against the emerging Omicron variants?
A: There have been some studies — some great studies — looking at things like neutralizing antibodies, which we use as a surrogate for clinical trials. But that is not the same as studying the outcome of interest, which would be hospitalizations. So, part of the challenge is to be able to say, "OK, this is what we know about the safety and effectiveness of the prior vaccines...and how can we relate that to outcomes with these new boosters at an earlier stage [before] clinical data is available?"
Q: How long will the new boosters' protections last — do we know yet?
A: That timing is still a question, but of course what plays a big role in that is what COVID strains are circulating. If we prep these boosters that are Omicron-specific, and then we have something totally new emerge...we have to be more nimble because the variants are outpacing what we're able to do.
This turns out to be a bit of a game of probability — the more infection we have, the more replication of the virus; the more replication, the more opportunity for mutations and subsequent variants.
Q: What about a combined flu-COVID vaccine; is that on the horizon?
A: My children, who like most children do not like vaccines, always tell me: "Mom, why can't they just put the influenza vaccine and the COVID vaccine into the same shot?" And I'm like, "Oh, from your lips to some scientist's ears."
At a time like this, where mRNA technology has totally disrupted what we can do with vaccines, in such a good way, I think we should push for the limits, because that would be incredible.
Q: If you've received a non-mRNA COVID vaccine, like those produced by Johnson & Johnson and Novavax, should you also get an mRNA booster?
A: Right now, the CDC guidelines do state that if your primary vaccine series was not with an mRNA vaccine then being boosted with an mRNA is a fine thing to do, and it's actually encouraged. So that's not going to change with the bivalent booster.
Q: Is it OK to get a flu shot and a COVID booster at the same time, as the CDC has recommended with past vaccines?
A: I don't anticipate there being recommendations against that. But I would also say watch for the recommendations that come out this fall on the bivalent boosters.
I do hope in the recommendations the CDC makes about the COVID boosters, they will say think about also getting your influenza vaccine, too. You could also get your COVID booster first, then by October get your influenza vaccine.
Q: Once you're fully boosted, is it safe to stop wearing a mask, social distancing, avoiding crowded indoor spaces, and taking other precautions to avoid COVID-19?
A: The virus is going to do what it does, which is infect whomever it can, and make them sick. So, if you see a lot of community transmission — you know who is ill with COVID in your kids' schools, you know in your workplace and when people go out — that still signals there's some increases in the circulation of virus. So, look at that to understand what your risk is.
If you know someone or have a colleague who is currently pregnant or immune-suppressed, think about how you can protect them with mask-wearing, even if it's just when you're in one-on-one closed-door meetings with that individual.
So, your masking question is an important one, and it's important for people to continue to hang onto those masks and wear them the week before you go see Grandma, for instance, to further reduce your risk so you don't bring anything to here.
The high-level community risk nationwide is high right now. COVID is here.
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Cite this: Nick Tate. New Omicron COVID Boosters Coming Soon: What to Know Now - Medscape - Aug 04, 2022.