The past three years have taught us a hard truth: Covid-19 does not pose the same risk to everyone it infects. Now, American public health agencies are trying to align Covid-19 vaccination recommendations with this fact.
This week, the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) Immunization Practices Advisory Committee launched streamlined vaccine recommendations aimed at helping people understand what to do right now.
In particular, the guidance elevates the bivalent vaccine introduced last fall as a tool for training immune systems to protect against both older and newer strains of the virus from booster status. Under the new recommendations, the bivalent vaccine can be used as the first and only vaccine a person receives as their primary vaccine.
The new guidance applies to updated bivalent formulations of mRNA vaccines manufactured by Moderna and Pfizer-BioNTech. The original vaccine series that most Americans received at the start of the pandemic is no longer available: Previously, monovalent formulations from Moderna and Pfizer are no longer licensed in the US, and others, such as Novavax and Johnsons and Johnsons, they were only rarely used here.
The result: for now, to be considered up to date, everyone should have at least one bivalent vaccine. However, only high-risk individuals should receive repeated bivalent vaccinations.
Furthermore, while previous vaccination with the older monovalent version of the vaccine was a prerequisite for bivalent vaccination, according to the new guidelines, even people who have not received any vaccine against Covid-19 can receive a bivalent injection.
Uptake of the bivalent vaccine has not been exceptional in the United States. Only 42% of people aged 65 and over who are at higher risk of serious illness and hospitalization due to Covid-19 received the injection. In all, less than 17% of all Americans have received a bivalent vaccine. In a statement, Peter Marks, director of the FDA’s Center for Biological Research and Evaluation, said, “The agency believes this approach will help encourage future vaccination.
It’s worth noting that both the FDA and the CDC used can and shouldn’t talk much of this guidance (with one important exception). At this point, these agencies are avoiding language that prompts anyone who has already been vaccinated to get another one. That’s because the data on revaccination isn’t strong enough to support telling someone they need another chance. Instead, the CDC and FDA highlight who is simply eligible for multiple doses.
Heres the result of the latest recommendations.
If you are a healthy person between the ages of 6 and 64 who has already received a bivalent vaccine
This one is the simplest: The FDA has said that for most people age 6 and older, one dose of the bivalent vaccine, regardless of when they took it, is enough for now.
It’s not that revaccination wasn’t protective against hospitalization in this age group this past fall and winter, the CDC said.
But lately, the risk of hospitalization has been so low among children and adults in these age groups, and the re-vaccination of the provided protection was so fleeting that it lasted only about two months that the re-vaccination of the bivalent would end up to be minimally advantageous in this group.
If you have never been vaccinated or have only aged, monovalent versions of the vaccine
The CDC has made its strongest and most explicit recommendation for people who have not yet received a bivalent vaccine, either because they have not yet received any Covid-19 vaccine or because they only got original, monovalent versions of the vaccine that were available before the outbreak. It’s August 2022. Those people should get a bivalent vaccine now, the agency said in a news release. This applies to everyone age 6 and older, and with so few Americans yet to receive a bivalent vaccine, this is the category most are in.
For people not yet vaccinated, the reasoning is that even though they may have some immunity against Covid-19 at this point due to a previous infection, most people have been exposed to the virus which is generally less protective against serious disease compared to the broader protection that appears to come from being both immunized and recovered from the infection.
For people who have only received monovalent versions of the vaccine, the rationale is that there is protection in the bivalent vaccine against not only the original strain of the virus, but also against the newer omicron variants, BA.4 and BA.5. And while very few of these strains are now circulating in the United States, they are still genetically closer to current strains than the original virus.
Therefore, a vaccine that trains the immune system to recognize both earlier and later strains of the virus is thought to provide better protection than one that targets only earlier strains.
If you are 65 or older
People aged 65 and older can also get a bivalent vaccine now, even if they have already received one. For this group, the rationale behind the FDA’s recommendation is that people 65 and older continue to be hospitalized for Covid-19 at higher rates than young adults. Over the fall and winter, those in this age group who had received bivalent vaccines died at much lower rates than those who hadn’t. For this group, the FDA has recommended waiting at least four months after the most recent bivalent dose to get a repeat dose.
If you are moderately or severely immunocompromised and aged 5 and over
According to the CDC, people who are moderately or severely immunocompromised include those who are or are about to be treated for cancer or receiving organ transplants, those with advanced or untreated HIV and certain congenital immunocompromising conditions, and those taking a variety of immunosuppressant drugs.
If you are moderately or severely immunocompromised and age 5 and older, you may also get a bivalent vaccine now, even if you have already received one. (Immunocompromised children younger than 5 years are ineligible for a repeat bivalent dose under the FDA’s new recommendations because the agency lacked data to justify it. Several pediatricians at this week’s CDC meeting expressed concern that that this decision has left a highly vulnerable group unprotected.)
There are a few reasons for this recommendation. For starters, this group may not have as robust an antibody response to Covid-19 vaccines. But another problem is that monoclonal antibody treatments that used to offer an extra layer of protection for immunocompromised people no longer work against omicron variants and are no longer cleared by the FDA except in unusual cases.
The FDA has recommended that immunocompromised people wait at least two months after their most recent bivalent dose to receive a repeat dose. They also said that people with certain types of immunocompromise such as those receiving or about to receive a stem cell transplant, B-cell-lowering drugs, or CAR-T cell treatment, some type of cancer therapy can continue to receive repeated doses every two months forward. People in this category should talk to their healthcare providers about what’s best for them.
Children aged 6 months to 5 years can receive bivalent doses if they are not vaccinated
Different manufacturers have different dosing regimens and different age thresholds for the pediatric versions of their bivalent vaccines: Modernas pediatric vaccine is given in a two-dose series for children 6 months to 17 years old, and Pfizers is given in a three-dose series. doses for children From 6 months to 4 years. So when it comes to children, it is less complicated to talk about complete or partial series than the number of doses.
Under the new guidelines, unvaccinated children can go straight to the full suite of bivalent vaccines, just like healthy young adults. Meanwhile, children who received the full or partial series of the older monovalent vaccines may also receive at least one dose of the bivalent vaccine. (How many they get will depend on how many monovalent doses they received and from which manufacturer. Parents should ask their pediatrician what to do for their child.)
Prepare for more changes in advance
This fall, when manufacturers likely release updated versions of the bivalent vaccine tailored to protect against the latest viral variants, the recommendations will likely change again.
But in the meantime, the new guidance lays out a game plan for most people on how to best protect themselves using vaccines.