Aug. 4, 2022 — New COVID-19 vaccine boosters, targeting new Omicron strains of the virus, are set to roll out in the United States in September — a month earlier than planned, 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” viral strain and elements of the Omicron BA.4 and BA.5 variants. Pfizer also announced a US$3.2 billion deal for an additional 105 million shots. Both vaccine providers have signed options to provide millions more boosters in the coming months.
About 83.5% of Americans have received at least one COVID-19 vaccine, including 71.5% fully vaccinated with the initial series, 48% receiving one booster and 31% two boosters, according to the CDC. With around 130,000 new COVID cases per day and about 440 deaths, officials say the updated recalls could help bring those numbers under control by targeting highly transmissible and widely distributed Omicron strains.
Federal health officials are still working out the details of guidelines and recommendations on who should receive the boosters, which should come from the CDC and the FDA. For now, authorities have decided not to extend eligibility for second boosters of existing vaccines – now only recommended for adults over 50 and those 12 and over with immune deficiencies. Children aged 5 to 11 are advised to receive a single booster, 5 months after their first series of vaccines.
For an overview 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 from that interview follow.
Q: Based on what we know now, who should get one of these new dual-purpose boosters?
A: Of course, there is a process here regarding specific recommendations, but it looks like 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 delay as to how long since the last reminder.
At this time, we have a recommendation for adults over 50 or adults who are at higher risk for severe COVID-related illness [to get] a second reminder. For them, there will probably be a timeline that says you should get the reminder if you’re X months or more away from your second reminder; or X months or more since your first reminder, if you have had only one.
Q: What about pregnant women or people being treated for chronic health conditions?
A: I imagine that once this bivalent booster becomes available, it will be recommended to all adults.
Q: What about children?
A: It’s a good question. It’s something I dug, [and] I think parents are really interested in that. Most children, ages 5 and up, are supposed to get a booster at this time, if they are 5 days away from their primary vaccine series. Of course these 6 months to 4.99 years are not yet eligible [for boosters].
As a parent, I would like to see my children become eligible for dual recall. It would be great if these boosters conveyed extra protection that kids could access before sending them off to school this fall. But there are questions as to whether that will happen or not.
Q: If you have never received a booster, but only the preliminary series of vaccines, do you need to obtain these previous boosters before receiving the new bivalent booster?
A: I don’t think they’re likely to make it a requirement – restrict bivalent booster only to those who are already boosted or up to date on their vaccines by the time bivalent booster becomes available. But it will be at [CDC] vaccine recommending committee to decide.
Q: Are there any new risks associated with these boosters, since they were developed so quickly?
A: No. We continue to monitor this technology, and with all the mRNA vaccines that have been delivered, you’ve seen all of this monitoring play out with detecting, for example, different forms of heart tissue inflammation and who that may impact . So these surveillance systems work, and they work really, really well, so we can detect these things. And we know that these vaccines are definitely safe.
Q: Some health experts are concerned that “vaccine fatigue” will impact the recall campaign. What is your point of view ?
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 early boosters with this new bivalent booster is important, because essentially what we’re doing is really priming the immune system.
We’re trying to speed up the process of upgrading people’s immune systems so that when the virus comes our way – as we know, because [of] these strains of Omicron that are highly infectious and really invading our communities – we are 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 recalls?
A: One of the things that I hear a lot, and it makes me very nervous, is people say, “Oh, I was fully vaccinated, whether or not I got the booster, and I got the COVID anyway and it was really nothing, it didn’t seem like much to me so I’m not going to be boosted anymore. We’re not quite in a place yet where those guidelines are overruled in any way. We still have people very vulnerable to serious illness and death in our communities, and we see hundreds of deaths every day.
There are consequences, even if not in the severity of the disease, ie hospitalization and death. And let’s not let the actual quality of the vaccine be so effective that it can keep you from going to the hospital. Don’t confuse this with “I don’t need another one”.
Q: Unlike the flu vaccine, which is reformulated every year to match circulating strains, new COVID boosters provide protection against older strains as well as newer ones. Why?
A: It’s about creating a broader immune response in individuals so that as more and more strains emerge, which they probably will, we can create a broader immune response in the population. [to all strains]. Our individual bodies see differences in these strains through vaccination which helps everyone stay healthy.
Q: There have been no clinical trials on these new mRNA boosters. How strong is the evidence that they will be effective against emerging Omicron variants?
A: There have been studies – large studies – on things like neutralizing antibodies, which we use as a surrogate for clinical trials. But that’s not the same as looking at the outcome of interest, which would be hospitalizations. So part of the challenge is being able to say, “OK, here’s what we know about the safety and effectiveness of previous vaccines…and how do we relate that to the results with these new, earlier-stage boosters [before] are clinical data available? »
Q: How long will the protections of the new boosters last? Do we already know that?
A: That timing is always a question, but of course what plays a big part in that is what strains of COVID are circulating. If we prepare these Omicron-specific boosters, and something totally new emerges… we have to be more agile because the variants are beyond what we are capable of.
It turns out to be a bit of a game of probability – the more infection we have, the more virus replicates; the more replication, the more possibilities for subsequent mutations and variants.
Q: What about a combined influenza-COVID vaccine; is it on the horizon?
A: My kids, who like most kids don’t like vaccines, always tell me, “Mom, why can’t they just put the flu shot and the COVID shot in the same shot?” And I’m like, “Oh, from your lips to a scientist’s ears.”
At a time like this, where mRNA technology has totally upended what we can do with vaccines, in such a good way, I think we should push the boundaries, because that would be amazing.
Q: If you have received a non-mRNA COVID vaccine, such as those produced by Johnson & Johnson and Novavax, should you also receive an mRNA booster?
A: Right now, CDC guidelines say that if your primary vaccine series wasn’t with an mRNA vaccine, then being boosted with an mRNA is a good thing to do, and it’s actually encouraged. This will therefore not change with the bivalent recall.
Q: Is it okay to get the flu shot and get the COVID shot at the same time, as the CDC has recommended with previous vaccines?
A: I don’t expect there to be any recommendations against it. But I would also say pay attention to the recommendations coming out this fall on bivalent boosters.
Hopefully in the CDC recommendations on COVID reminders, they say to also think about getting the flu shot. You can also get your COVID booster first, then in October get your flu shot.
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 will do what it does, which is to infect whoever it can and make them sick. So if you see a lot of community transmission – you know who’s sick with COVID in your kids’ schools, you know in your workplace and when people go out – that’s still a signal that there’s an increase in the circulation of the virus. So, watch this to understand what your risk is.
If you know someone or have a colleague who is currently pregnant or immunocompromised, think about how you can protect them by wearing a mask, even if it’s only when you’re one-on-one with that person. . .
So your masking question is important, and it’s important that people continue to hang on to those masks and wear them the week before they go to see grandma, for example, to further reduce your risk so that you brought nothing here.
National high-level community risk is elevated at this time. Covid is here.