Which COVID-19 vaccine did you get? This is a question that physicians and other health professionals continue to hear as vaccine rollout continues. While there are now three vaccines available that have received emergency use authorization in the United States—those made by Pfizer-BioNTech, Moderna and Johnson & Johnson-owned Janssen Pharmaceuticals—it is less important which one a person gets. Instead, says a leading physician expert, it is imperative that everyone simply gets vaccinated.
“We now have three COVID-19 vaccines, and all three are safe and effective,” said Sandra Fryhofer, MD, an Atlanta general internist who serves as the AMA’s liaison to the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP). Dr. Fryhofer also is a member of ACIP’s COVID-19 Vaccine Work Group.
Whether it is Pfizer, Moderna or Johnson & Johnson (J&J), “ACIP has expressed no preference for any of these three authorized vaccines,” Dr. Fryhofer said. What is preferred is to “get vaccinated as soon as you can, when it's your turn.”
“The companies really have done a good job in trying to mirror their study to represent the real world,” she said. “Everything just happened a lot quicker than what we're used to, which is good. Now the next thing we've got to do is our job and take advantage of this gift that's been given us.”
“Vaccination has now been opened up to everyone 16 and older—it’s just a matter of signing up, showing up and coming back for a second vaccine dose if indicated,” said Dr. Fryhofer. “However, women under 50 should be made aware of the rare risk of blood clots and low platelets following Janssen COVID-19 vaccination. They should also be made aware there are other vaccines available that don’t pose this small risk.”
As the country navigates COVID-19 vaccine distribution, Dr. Fryhofer—a member of the AMA Board of Trustees—took time to discuss how to respond to patients’ questions about vaccination type.
Physicians should share which COVID-19 vaccine they received, said Dr. Fryhofer. “I was able to get two doses of a vaccine, so now I tell patients which one I got. I didn't care which one it was. I just wanted to get a dose of a vaccine.”
But “the considerations have somewhat changed since the FDA amended Janssen’s emergency use authorization to include the warning about the rare risk of blood clots and low platelets—called TTS, or thrombosis with thrombocytopenia syndrome,” she said, adding that “women under 50 may decide to choose one of the mRNA vaccines by Pfizer or Moderna that do not carry this risk.”
It is important for physicians to tell their patients, “You have to decide if you're going to get vaccinated,” she said. “My recommendation to you is to go for it. Take the one you can get, but read the fact sheets about the vaccine first.”
The fact sheets “review side effects to expect and also TTS symptoms to look for,” said Dr. Fryhofer, adding that it also “urges seeking medical attention if you have them. This is especially important for women under 50.”
While J&J’s Janssen vaccine has 66.3% effectiveness overall and 74.4% effectiveness in the United States, many people think that because “Moderna is 95% effective, this one can’t be as good,” she said. But “you really can’t compare them. It’s like comparing apples to oranges.”
“The Pfizer, Moderna and Janssen vaccines were tested at different times, different places, different geographies,” Dr. Fryhofer said. “You can't put them head to head because they each stand on their own.”
For example, “Pfizer and Moderna trials took place early in the pandemic,” Dr. Fryhofer explained. But “when the Janssen vaccine was tested, background COVID incidence was higher with more circulating variants, some of which can increase transmissibility and disease severity.”
“All three vaccines far exceeded FDA's bar of 50% efficacy,” she said, adding that the pause in J&J Janssen vaccine administration further demonstrated that the Vaccine Adverse Event Reporting System is working.
Among nearly 8 million doses of the J&J vaccine administered through April, the Food and Drug Administration (FDA) and CDC reviewed data involving 15 reported cases in the U.S. of cerebral venous sinus thrombosis with thrombocytopenia (TTS) in people receiving the vaccination. Most were in women between 18 and 49, with symptoms developing six to 13 days after vaccination.
Overall, These adverse events appear to be extremely rare—1.9 cases per million—but COVID-19 vaccine safety is a top priority and health problems following vaccination are taken seriously. The reporting rate is higher for women under 50 at seven per 1 million and highest for women in their 30s at 11.8 per million. For women 50 and older, the reporting rate is less than one in 1 million.
Since the pause was lifted April 23, the J&J Janssen vaccine is recommended for those 18 or older under an amended FDA emergency use authorization, which includes additional warnings and precautions, especially for women under 50.
AMA President Susan R. Bailey, MD, commended ACIP for “reaffirming its recommendation on the use of the Janssen COVID-19 vaccine” for those 18 or older under the FDA’s emergency use authorization. “The population-level data presented during ACIP’s meeting … clearly demonstrates that the benefits of this approach outweigh the risks,” she said.
“The pause on the Janssen COVID-19 vaccine has demonstrated the strength of our nation’s vaccine safety monitoring system and the transparent and careful deliberations by the ACIP should raise confidence in FDA-authorized and CDC-recommended COVID-19 vaccines,” Dr. Bailey added. “The AMA continues to encourage everyone who is eligible for COVID-19 vaccines to get vaccinated as soon as possible.”
While the J&J vaccine pause has been lifted, some people might still be worried. But “the United States has authorized use of two other safe and highly effective COVID vaccines, which use a completely different platform,” said Dr. Fryhofer. “Pfizer and Moderna mRNA vaccines are completely different and more than 180 million doses of mRNA COVID vaccines have been administered.”
Additionally, “there have been no reports of cerebral venous sinus thrombosis combined with thrombocytopenia in patients who have received mRNA vaccines by Pfizer or Moderna,” she said, emphasizing that “this rare, but deadly combination of blood clots and low platelets has not been seen with Pfizer and Moderna mRNA COVID vaccines.”
“Fortunately, based on current projections, the supply of both of these mRNA vaccines is fairly high and looks stable for at least the near future,” said Dr. Fryhofer, adding that “we need to encourage our patients to get vaccinated. This is the only way we can end this pandemic.”
Which vaccine a patient gets is dependent on the vaccination site. While one site may get Moderna, another might have Pfizer-BioNTech and then others might get J&J’s COVID-19 vaccine.
“My hospital has both the Moderna and the Pfizer, but the most important thing is whatever you get for the first dose, you have to get for the second dose—there’s no mixing and matching,” she said. “You want to get the full series.”
“One big advantage of the Janssen vaccine is it only requires one dose,” said Dr. Fryhofer. “This means you don’t have to come back for a second appointment. It also means only one set of vaccine side effects.”
Read about why data doesn’t back altering doses for COVID-19 vaccination.
“If you go someplace and they’re wanting you to pay for the vaccine, that is a red flag,” said Dr. Fryhofer. “We have all paid for these vaccines, with our tax dollars, through Operation Warp Speed.
“Now, you might be asked to show your insurance card,” she added. “The places that do administer vaccines are allowed to bill your insurance company for the administration fee, but you should not be paying.”
“I would also encourage patients to go on their department of health website and take a look at the forms that are being offered and read them,” said Dr. Fryhofer. “They're going to have to read and understand them sooner or later, and that also can give you a feel as to whether or not this place is legitimate.”
However, “the best bet is to call your physician,” she added.
“Trust and open communication are so important,” said Dr. Fryhofer. “If you don't tell people what to expect, physicians are going to be sorry because they're going to get phone calls from patients about side effects.”
That is because after getting a COVID-19 vaccine, “most people are going to have some sort of side effect,” she said. All three vaccines “are going to cause a sore arm. You may feel a little bad, maybe a little tired, muscle aches, but it is so much better than getting COVID—and you do have to get that second dose.”
“You do expect to have more side effects with that second dose—only for Pfizer and Moderna,” said Dr. Fryhofer, adding that “if day one is the day you get vaccinated ... most symptoms are going to be on day two, day three, possibly day four and then they're usually gone. But for some people, they're enough to make you not be able to go to work.”
Additionally, with the J&J “vaccine, it’s one dose and you’re done, so you don’t have to go for a second dose,” she said. “It’s just the one time, but for our patients that means you’re only going to have side effects one time.”
“But given concerns about 15 cases of thrombosis and thrombocytopenia, CDC and FDA warn that patients who have received the J&J vaccine within the past three weeks should notify their physician and seek medical evaluation if they develop shortness of breath, chest pain, leg swelling, persistent abdominal pain, neurological symptoms including severe or persistent headache or blurred vision, or petechiae beyond the site of vaccination,” said Dr. Fryhofer, adding that “the risk of this concerning combination of blood clots and low platelets is rare but serious.”
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Once a patient does receive their first dose of a COVID-19 vaccine, Dr. Fryhofer recommends signing up for the V-safe vaccination health checker, which is a smartphone-based tool from the CDC.
“They'll text you every day and you can tell them what your symptoms are, because you're going to share your experience with others and everyone can learn from your experience,” said Dr. Fryhofer, adding that it is important to not only sign up for v-safe, but to also “get that second dose.”
The AMA has developed frequently-asked-questions documents on COVID-19 vaccination covering safety, allocation and distribution, administration and more. There are two FAQs, one designed to answer patients’ questions, and another to address physicians’ COVID-19 vaccine questions.
Watch this episode of the AMA webinar series, “COVID-19: What physicians need to know,” where Peter Marks, MD, PhD, discusses the Johnson & Johnson COVID-19 vaccine pause with AMA President Susan R. Bailey, MD.
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