A woman receives a vaccination shot for COVID-19. (CDC | Unsplash)
Following the announcement from the federal government that, in addition to booster shots for the Pfizer COVID-19 vaccine, booster shots will be available for recipients of the Moderna and Johnson & Johnson vaccines, Dr. Ryan Westergaard, chief medical officer in the Department of Health Services (DHS) Bureau of Communicable Diseases and Stephanie Schauer, Ph.D., immunization program manager in the DHS Division of Public Health, joined a media call on the current status of COVID-19 efforts in Wisconsin. The questions and answers from that call, on Friday Oct. 22, have been edited here for clarity and brevity.
Who should be getting COVID-19 booster shots?
Ryan Westergaard: The recommendations for a booster are for people who have completed the primary series of the vaccines and then a specified amount of time has gone by: six months for the [Pfizer or Moderna] mRNA vaccines; two months under the new forthcoming guidance related to the Johnson & Johnson vaccine. We recommend people for the booster if they’re in that highest age group of 65 and older or if they’re at frequent increased risk in occupational settings.
Household contact by itself [with someone who is recommended to get a booster] wouldn’t put [a person] into the category of needing a booster. People who might want to consider boosters are people who work in health care or educational settings who are potentially at high increased repetitive risk of [exposure to] COVID-19.
Who is now considered ‘fully vaccinated’?
Stephanie Schauer: We’re emphasizing that the primary series [two doses of Pfizer or Moderna or one dose of Johnson & Johnson] is key and important — that’s considered fully vaccinated. Some individuals who are at increased risk either due to age, occupation or medical condition may need an additional dose, but that is not part of what we consider fully vaccinated.
Have Wisconsin nursing homes started giving booster shots?
Schauer: Yes. There are individuals in long-term care facilities who are immunocompromised and are receiving third doses. Many long-term care facilities, when we initially rolled [the vaccine] out, were receiving the Moderna vaccine. The new information is now the authorization to start [booster shots for those folks who have received Moderna.
The CDC guidance is now saying that people can mix and match vaccines — for example, if you got the Pfizer vaccine, you could get a Moderna booster. Are there any recommendations for staying with the same brand if you are getting a booster?
Westergaard: Both the FDA authorization and the ACIP [Advisory Committee on Immunization Practices] clinical recommendations allowed for mixing and matching the vaccine. They’re not recommending that people use a different combination of vaccines, and we don’t have any evidence that one mixture or one regimen is better than any other. We do have evidence that all the vaccine products are safe and effective, and there has been some clinical data that they have been used in combination successfully and safely.
The rationale behind allowance mixing doses was to provide more flexibility. But the main data presented was for booster doses in the same category. So as a clinician, I would consider that to be the default. And the primary recommendation is to use the same product for all three doses — or two doses if it’s the Johnson & Johnson — but there’s evidence that it’s safe to do otherwise. We don’t have any evidence comparing one regimen head to head, so we don’t make a recommendation to do one way or the other.
Will the doses of vaccine be ready once the 5-to-11 age group is ready for the vaccine?
Schauer: Wisconsin has been allocated an allotment of pediatric vaccine in anticipation of their approval. Vaccinators need to have a number of steps in place before they can actually start vaccinating; vaccine is just one of them. They need to ensure that they have all of the proper clinical guidance and recommendations from ACIP in writing, because it’s important as we move into the new groups that everybody is doing this safely and consistently. They need to make sure they have the appropriate fact sheets and that they’ve trained staff. There’s an art and a science to vaccinating pediatric patients. We’re doing all that we can to prepare vaccinators in advance to ensure that they have properly trained staff.
With the addition of boosters, will we see vaccine mandate requirements change from requiring individuals to be “fully vaccinated” to requiring them to be “up to date on their COVID-19 vaccination”?
Westergaard: [It] remains our goal for everybody to get a primary vaccine series. We can look at boosters as a way to optimize or maximize the benefit, or to make sure that benefit lasts longer. But I think we’re still considering the primary series to be the key difference between someone who is at risk of severe COVID-19 and someone whose risk has been dramatically reduced through vaccination. There are still many millions of people in the country that haven’t received their initial series. Our public health priority is to promote the primary vaccine series as the way to prevent hospitalizations and deaths.
How does booster availability affect how the state is managing supplies of vaccinations, including wasted doses and the lack of demand in particular areas?
Schauer: It’s important to note that vaccinators have been able to order the amount of vaccine that they need. In anticipation, they’re going ahead and ensuring that they have appropriate vaccine and making sure that the public is aware through vaccines.gov. Vaccination has plateaued a bit, but we anticipate with more people now being eligible for these booster doses, that we will see that amount go up. Where clinics are administering doses, it can either be boosters, or it can be the primary series. The important thing is that vaccine continues to be administered, and that we’re not losing any opportunity to provide vaccine versus letting unopened vials sit in the refrigerator and not providing any protection to anyone.
Some parents of small children have been impatient to see final approval for vaccines for 5- to 11-year-olds. What message would you want to give to people who seem to feel that the FDA and CDC are not recognizing the urgency to expand that accessibility?
Westergaard: As a parent of a 9-year-old and an 11-year-old, I consider myself among the group that is maybe impatient or eagerly awaiting that decision — but not among those who feel like the regulatory authorities are not acting with the appropriate urgency.
One of the things that has required the process to take longer for the younger age groups is making sure that we’re giving the right dose. It’s not enough to say, ‘We’ve got a safe and effective vaccine for adults, let’s just extrapolate and give that to our children,’ for a couple of reasons. One is that they’re smaller; many medicine doses are weight-based; [younger children] may not need as high of a dose, and the risk of side effects might be higher with a higher dose than a lower dose. So it wasn’t something that’s in anyone’s interest to make a guess about. We needed the data to show what dose is optimal for younger people with smaller bodies. For people who think that the process is not happening fast enough, I’m sympathetic to that. But the process is so critically important, and it’s, in my opinion, so appropriately rigorous, because when we start making recommendations for millions of children, we want to be able to stand behind very solid science that we’re recommending something for which the benefits clearly outweigh the risks. We need to have very good studies that are carefully conducted, and that’s what we have. That’s what the FDA is going to be reviewing [this] week. And then, if the FDA authorizes it for that younger age group, then the clinical experts from ACIP will scrutinize the data again and make clinical recommendations. The process can’t be kicked off fast enough for those of us who are eager to get our children immunized, but it’s happening as fast as it can, and that’s something that we should all be very, very proud about and have a lot of trust in this process.
Why is the Johnson & Johnson booster proposed to be offered for anyone 18 and older after two months, whereas the Moderna and Pfizer are first recommending them for people who are at risk for increased exposure and after six months?
Westergaard: The recommendation reflects what the evidence says is appropriate. They’re different because these vaccines are different kinds, they were developed with a different strategy and tested a different time, with [for Johnson & Johnson] a single dose as opposed to a two-dose series initially. The recommendations are based on the science that’s been generated as we’ve observed these first six to nine months after the vaccine has been in use.
When shots become available for 5- to 11-year-olds, will that take place at a pediatrician’s office, at clinics or at schools?
Schauer: We’re really looking towards the broad, robust network of vaccinators that we already have in place. Pediatricians and primary care are a couple of the really important ones. Also we’re talking about local health departments, pharmacies, and schools may be planning clinics on site at school, either during the school day or after school hours when parents can bring their children. It’s going to require a broad network of vaccinators to go ahead and continue vaccinating not only the pediatric patients, but also all of the other individuals who are either presenting for primary series, or now who may be eligible for boosters. We’ve got over 2,000 registered COVID-19 vaccine providers and are continuing to encourage them and provide information, making sure that they are ready to vaccinate those younger folks when it becomes available.
Has the DHS staff begun discussing or planning in anticipation of COVID-19 becoming an endemic and perhaps seasonal disease, perhaps requiring regular boosters annually?
Westergaard: The advance planning acknowledges that this virus is going to be with us for some time. It’s already been shown that single doses of vaccines don’t confer lifelong protection. And we don’t have anywhere near 100% uptake of vaccines. So the probability that this SARS-CoV-2 virus is going to continue to circulate around the world is nearly assured. Time will tell whether vaccine boosters will be a more regular thing. There are some vaccine series [for other illnesses] for which three doses is a complete series, and you don’t need another one. As everyone knows, there are other vaccines like influenza for which we get an annual booster. Where this fits along that spectrum, it really remains to be seen. We’ll know a year from now when we see the long term studies of people who got a booster dose six months out. The level of vaccine efficacy might wane 12 months down the line, and I anticipate there will be ongoing studies from the same vaccine manufacturers about what is the role for additional vaccines.
I think we can safely predict that we are already in a situation where the virus is endemic. We’re living with it. We’re still in pandemic response mode, because we have so many people who have not been vaccinated at all, which means there’s still high stakes: We still have a lot of lives that we can save by promoting vaccination, by using the mitigation strategies to reduce transmission in the community to as low as we can. Once everyone has the opportunity to get vaccinated, we’ll have some new normal, where we live with this virus, we probably don’t wear masks indoors all the time. And then there’s some schedule by which people may or may not need additional doses. Other respiratory viruses circulate with seasonal variation; we have to prepare for bad flu seasons. We have to [confirm that] vaccines are still working, or [if it’s necessary] to modify them. I think all of those things are in our future when we talk about the future of living with SARS-CoV-2 and COVID-19.
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