This week, the FDA authorized Novavax’s updated COVID-19 vaccine. The CDC’s fall vaccine recommendations were already set up to include Novavax once it was authorized, so pharmacies and health providers can start administering it without any additional hurdles at the federal level.
Novavax’s new vaccine, like the options from Pfizer and Moderna for this fall, is designed to protect against XBB.1.5, a recently circulating variant that is closely related to most of the strains causing disease in the U.S. right now. But unlike the Pfizer and Moderna vaccines (which use mRNA technology), Novavax’s uses a piece of viral spike protein to teach recipients’ immune systems how to recognize the coronavirus.
Some scientists and health advocates I follow have been particularly looking forward to the Novavax authorization, hoping to get their shot rather than one of the mRNA options. There are two main reasons for this choice, based on my reading:
The Novavax vaccine may have fewer or easier side effects than the mRNA vaccines. This is particularly appealing for some people who had poor reactions to earlier mRNA vaccine doses (including, in some cases, long-term issues similar to Long COVID), and some people with chronic conditions.
Some experts say that “mixing and matching” different types of vaccines might lead to a more robust, long-term immune response against the coronavirus, compared to sticking with one vaccine type.
A recent article in Science goes into more detail about these considerations. Writer Jennifer Couzin-Frankel walks through scientific studies that look at Novavax compared to the other vaccine options, and explains some of the questions that we don’t have sufficient data to answer yet. For example, as fewer people have received Novavax vaccines compared to the mRNA options, it’s harder to see signals for potential rare adverse reactions. More studies are coming in that will help address these questions, but for now, many people are making personal choices about which vaccine to get this fall.
Last week, I asked you, COVID-19 Data Dispatch readers, to send me your stories of challenges you experienced when trying to get this fall’s COVID-19 vaccines. I received 35 responses from readers across the country, demonstrating issues with insurance coverage, pharmacy logistics, and more.
I’ve published the full responses in the table below. Here are a few common themes that I saw in these stories:
Pharmacies aren’t receiving enough vaccines. Several readers shared that their pharmacies had inadequate vaccine supply to accommodate all the people who made vaccination appointments, or who wanted appointments. Vaccine supply may also be unpredictable—a pharmacy may think they’re getting more shots, but in fact not receive them—leading to appointment cancellations.
Insurance providers weren’t prepared for this vaccine rollout. Despite months of advance notice that a fall COVID-19 vaccine was coming, many insurance companies apparently failed to prepare billing codes or other system updates that would allow them to cover the shots. A couple of people who shared insurance issue stories are on Medicare—representing a population (i.e. seniors) who should be at the front of the vaccine line.
Very limited, confusing vaccine availability for young kids. Several readers shared that they were able to get vaccinated, but their children under 12 have not received a vaccine yet. While the FDA and CDC have authorized this fall’s COVID-19 vaccines for all Americans ages six months and older, younger children require a different vaccine formulation from adults. And this formulation appears either entirely unavailable or very difficult to access, depending on where you live.
People living in less dense areas may need to travel. A few readers shared that, as they searched for vaccine appointments in their areas, the closest pharmacies with doses available were miles away—over 10 miles, in one case. This is a significant barrier for people fitting vaccine appointments into their work schedules.
Information may be inconsistent. Vaccine availability listed in one place (such as a pharmacy chain’s website or the federal vaccines.gov website) may be inaccurate in another. Some readers shared that they spent extra time on the phone with pharmacies or health providers to get accurate information—another barrier.
Pharmacies don’t have enough staff for this. Even readers who were able to receive COVID-19 vaccines often had to wait a long time at their pharmacies. Several shared that their pharmacies appeared to be understaffed, dealing with the COVID-19 shots along with routine prescriptions and other duties. The days of mass vaccination sites, efficiently run by public health departments, are long over.
Kaiser Permanente members face delays. One company that appears to be causing outsized problems is Kaiser Permanente, one of the biggest insurers and health providers on the West Coast. Several readers shared that Kaiser was not providing new COVID-19 vaccines until early October, and would not cover the shots if their members went to another location. That’s a big delay, and it may be further impacted by a coming strike at the company.
These vaccines are expensive. If you decide to pay for a COVID-19 shot out-of-pocket (as some readers did), it costs almost $200. Even the federal government is paying about triple the cost of last year’s COVID-19 vaccines per shot, for the doses it is covering, STAT News reports. The U.S. may have received a “bad deal” here, STAT suggests, considering all of the federal funding that’s supported vaccine research and development.
As I wrote last week, some news outlets have covered these challenges, but this issue really deserves more attention. The updated COVID-19 vaccines are basically the U.S. government’s only strategy to curb a surge this winter, and they should be easily, universally accessible. Instead, many people eager to get vaccinated are going through multiple rounds of appointments, phone calls, pharmacy lines, and more.
For every one of these readers who has persisted in getting their shot, there are likely many other people who tried once and then gave up. And those people who don’t receive the vaccine will be at higher risk of severe illness, death, and long-term symptoms from COVID-19 this fall and winter. This is a public health failure, plain and simple.
And it’s important to emphasize that this failure is not surprising. Many health commentators predicted that these challenges would arise as the federal public health emergency ended and COVID-19 tools transitioned from government-funded to covered-by-insurance. For more context on why this is happening, I recommend the Death Panel podcast’s latest episode, “Scenes from the Class Struggle at CVS.”
If you’re a reporter who would like to connect with one of the COVID-19 Data Dispatch readers who shared a story, please email me at betsy@coviddatadispatch.com. Most of the people in the database below shared an email or other contact info.
Data from a CDC presentation suggest that people of all ages, including children, receive a benefit from updated COVID-19 vaccines.
We now have two new COVID-19 vaccines available for this year’s respiratory virus season, one from Pfizer and one from Moderna, which are expected to perform well against current variants. The FDA approved both vaccines this week, and the CDC recommended them for almost all Americans. A third option, from Novavax, may become available in the coming weeks as well.
The federal government aims to present this fall’s shots as the next iteration in routine, annual COVID-19 vaccines—similar to the routine we’re all used to for flu shots. In fact, I’ve seen some news suggesting that the federal health agencies don’t want us to call these shots “boosters,” instead calling them “updated” shots or annual shots.
But this fall’s vaccine rollout is likely to be anything but routine, as it’s the first rollout following the end of the federal COVID-19 public health emergencies. The government is no longer purchasing shots and distributing them for free; now, insurance companies will have to cover the shots.
As a result, many Americans—especially those without health insurance—will have a harder time accessing these vaccines than they have for previous shots. Plus, the federal emergency’s end will make it harder for us to track how the vaccines are performing, as the coronavirus continues to evolve into new variants.
With all of these complications in mind, here are ten key facts and statistics that you should know about this fall’s COVID-19 vaccines.
Pfizer and Moderna’s shots have been approved and recommended for all Americans, ages six months and older.
Despite some debates among scientists about whether younger people really need updated COVID-19 shots, the FDA has approved these vaccines—and the CDC has recommended them— for all age groups. This is important because CDC recommendations are often the basis for insurance coverage, as experts explained at a webinar hosted by the National Press Foundation on Tuesday.
The shots exclusively target XBB.1.5, a coronavirus lineage that is common in the U.S. and globally right now.
According to the CDC’s genomic surveillance program, almost all cases in the U.S. in recent weeks have been caused by XBB.1.5 or related variants from the XBB lineage. Variants like EG.5 and FL.1.5.1 are also XBB descendants, which have been given nicknames to make it a bit easier for scientists to keep track of them.
It’s also important to note that, unlike last year’s boosters, this fall’s shots are monovalent vaccines—meaning they only target XBB.1.5. The shots no longer target the original strain of SARS-CoV-2 that first circulated in 2020. Scientists generally approve of this choice, as the virus has mutated so much since that time.
Moderna’s booster led to a 17-fold increase in antibodies against XBB.1.5 and XBB.1.6.
The vaccine companies presented data to the CDC’s vaccine advisory committee on Tuesday. Moderna’s presentation included results from a study testing its new vaccine against several different variants, using blood samples from people who received the booster.
About one month after vaccination with Moderna’s booster, the participants had about 17.5 times more neutralizing antibodies against XBB.1.5, 16.7 times more against XBB.1.6, 14 times more against EG.5.1, and 10 times more against BA.2.86. Pfizer also presented data, suggesting that their vaccine should similarly perform well against current variants.
The new vaccines should lead to similar side effects as we’re used to from past mRNA shots.
Based on data that the vaccine companies presented to the CDC’s committee, this fall’s Pfizer and Moderna vaccines should lead to similar side effects—headache, fatigue, muscle pain, etc.—as many of us have expected from past rounds of COVID-19 shots. The companies, along with the CDC and FDA, will continue to monitor these vaccines for any safety issues that may emerge as people start to get them.
Young, unvaccinated children are at higher risk for COVID-19.
One of the CDC presentations focused on how this fall’s vaccines may benefit young children. Last fall and winter, hospitalization rates were higher for COVID-19 than for the seasonal flu across all young age groups, from infants (under six months) to 12-17 years old. The vast majority of the children hospialized were not vaccinated or hadn’t received last year’s booster.
For some CDC advisory committee members, these data were convincing in suggesting that this fall’s vaccine should be recommended for children, experts told STAT News. Vaccines updated to match current variants have a clear benefit for all age groups.
Long COVID remains a significant risk for Americans across age groups.
Another CDC presentation discussed Long COVID, as one of the potential adverse outcomes of a COVID-19 case. The CDC shared new data from a national survey conducted in 2022, which suggests that 9% of Americans ages 35 to 49 have experienced Long COVID symptoms (defined as symptoms lasting at least three months after a COVID-19 case). Adults ages 50-64 and 18-34 also reported high levels of Long COVID, at 7.4% and 6.8% ever experiencing symptoms, respectively.
Many studies have shown that vaccination lowers risk of Long COVID, though it does not by any means eliminate this risk. While it’s good to see the CDC incorporating Long COVID into its vaccine risk/benefit discussions, much more research is needed to better understand how to prevent this debilitating condition.
A Novavax vaccine is still in the pipeline.
Novavax also presented data to the CDC’s advisors this week, suggesting that its vaccine (also based on XBB.1.5) should perform similarly to the Pfizer and Moderna options. But unlike the Pfizer and Moderna vaccines, Novavax’s has yet to receive FDA approval. The company has said it’s still planning to distribute its vaccine this fall, but it’s unclear when the FDA may authorize it.
Some people are eager to receive the Novavax vaccine this fall, rather than Pfizer or Moderna’s, because this vaccine uses a different mechanism to boost the immune system. It may also lead to fewer side effects than the mRNA vaccine, making it a potentially good option for people who’ve had particularly strong reactions. (I know a couple of readers have sent me questions about this, and aim to do a deep-dive on Novavax in a future issue.)
Only 17% of Americans received last fall’s bivalent booster.
The booster uptake last year was low, according to the CDC. Even among seniors, only 43% received the booster. Can we do better this year?
A POLITICO/Morning Consult poll found that about 60% of respondents said they “probably or definitely” would get this year’s vaccine. (The poll included about 2,000 registered voters from across the U.S.) But it’s likely that access issues could get in the way for many people, as getting this COVID-19 vaccine will be much more challenging than it’s been in past rollouts.
HHS program should provide free vaccines for 25-30 million adults.
The Department of Health and Human Services has officially launched its “Bridge to Access” program, designed to provide free COVID-19 shots to uninsured Americans. Through this program, the HHS is essentially buying a small number of shots and distributing them to pharmacies, federally supported health centers, and other providers. You should be able to view these providers at vaccines.gov, according to the HHS. But I’ll be curious to see how well that actually works.
This year’s vaccine rollout will be much harder to track.
In the past, I’ve written about how the U.S. has failed to monitor breakthrough cases, or COVID-19 infections that occur after someone is vaccinated (and the hospitalizations, deaths, and long-term symptoms that may result). This year, not only are we failing to track breakthrough cases—the U.S. no longer has any national case data at all. We also no longer have vaccination data, as the CDC is not collecting this information from state and local health systems.
So, how will we know how this year’s vaccine rollout goes? It’ll likely be a lot of guesswork, extrapolating from a few state/local health departments, polling data, and other smaller-scale research to estimate how many people are getting vaccinated nationally. This challenge is just another example of the damage that the federal government has done in the last year by dismantling many of its COVID-19 data systems.
This past Thursday, the FDA’s advisory committee on vaccines and similar biological products met to discuss COVID-19 boosters for this fall. They voted in favor of updating the vaccines based on Omicron XBB, a variant lineage that has dominated both in the U.S. and globally this year.
The fall boosters will be monovalent, meaning they’ll only include the XBB strain—unlike our most recent boosters, which were bivalent (including BA.4/BA.5 and the original, Wuhan strain). The FDA has recommended this switch because research suggests monovalent vaccines may be more effective, and because the original coronavirus strain is no longer circulating; we’re mostly seeing XBB right now.
The FDA has not yet decided which exact variant will be used for this fall’s boosters. While experts generally agree that it should be an XBB lineage, the FDA will make a final call on this closer to the fall respiratory virus season. XBB.1.5, XBB.1.9, and XBB.1.16 are all major contenders right now.
This fall’s vaccination campaign is likely to prioritize at-risk populations, including seniors and those with medical conditions that damage their immune systems, similar to the bivalent booster shot rollouts. Ongoing vaccine effectiveness research suggests that these groups benefit most from the protection of an additional booster shot, though people not in these groups obviously benefit as well.
The CDC will make final decisions about which groups will most need the fall boosters, as well as whether some groups may be eligible for more than one of the shots. Children may also become eligible for new boosters; that’ll be up to the CDC as well.
In choosing XBB for the fall boosters, the FDA is standardizing with recommendations from the World Health Organization and European Union, which have also suggested that XBB be the target for the next boosters. Last year, the WHO recommended BA.1, while the U.S. used BA.4/BA.5. Standardizing will be helpful for ongoing data collection, since…
Data problems persist: I’ve written a lot about the U.S.’s disadvantages in tracking vaccine effectiveness, particularly compared to other countries with more standardized health systems. This problem has persisted through all rounds of boosters, including the shots planned for this fall; in fact, it’s even harder now for U.S. agencies to monitor how well the vacines work, as the federal public health emergency’s end led to fewer data collection authorities for the CDC. (Safety monitoring systems will continue, though.)
It’s also worth noting that the boosters this fall will be the first major COVID-19 vaccine rollout following the end of the federal public health emergency. While the Biden administration has devoted some funding for getting vaccines to uninsured Americans, most people will now be getting vaccinated through their health insurance.
This is certain to make the process more complicated and more challenging for many. I’ve already seen stories of people who are eligible for a second bivalent booster having a hard time getting that shot. (See this recent Death Panel episode, for example.) The federal government is doing very little to improve this situation in time for the fall boosters to arrive—and no matter how well XBB vaccines work in theory, they’ll do little in practice if nobody can actually get them.
COVID-19 Data Dispatch 