After receiving emergency usage authorization indigenous the Food and also Drug management (FDA) and recommendation from the Centers for disease Control and Prevention (CDC), Johnson & Johnson-owned Janssen Pharmaceuticals ended up being the 3rd company to make its coronavirus vaccine obtainable in the country. The Johnson & Johnson (J&J) SARS-CoV-2 famous vector vaccine joined mRNA vaccines made by Pfizer-BioNTech and Moderna to help prevent an ext severe COVID-19 outcomes, consisting of hospitalizations and also death.

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Get reliable info on breakthroughs in the authorization, circulation and management of COVID-19 vaccines.

J&J’s one-shot vaccine for adult was another major step towards vaccinating millions of people throughout the country. When its single-dose, easy-to-store logistical benefits make the an attractive option, it’s essential to understand what to suppose with the Johnson & Johnson COVID-19 vaccine and also the need for a booster shot.

The AMA’s What doctors Wish patient Knew™ collection provides medical professionals with a communication to re-superstructure what they want patients to understand around today’s health care headlines, specifically throughout the COVID-19 pandemic.

In this installment, two physician professionals took time come share what patients have to know around the J&J vaccine. Castle are:

Mira Irons, MD, president and CEO that the college of physicians of Philadelphia. In a former role, Dr. Irons served as cook health and also science officer at the AMA.
One dose is a complete vaccine series

One dose is a complete vaccine series

The J&J vaccine “is the very first authorized vaccine to call for one dose instead of two,” said Dr. Irons during an illustration of the “AMA COVID-19 Update” around the Janssen COVID-19 vaccine.

“A Janssen vaccine collection is quiet a solitary dose the vaccine it is designated in Janssen’s emergency use authorization native FDA,” said Dr. Fryhofer, a member of the AMA board of Trustees. “One sheep is still considered a complete dose series for public wellness purposes, however now a booster is recommended at the very least two months later for everyone 18 and also older who has actually received a single Janssen dose.

associated Coverage Moderna and also J&J COVID-19 vaccine boosters: What medical professionals must recognize

“Some experts say Janssen should have actually been a two-dose vaccine from the beginning,” she added. “When and also if Janssen receives full FDA approval, the one dose recommendation could change and possibly become two, however that has actually not occurred yet and also it may not. It will certainly be amazing to see what happens.”

Additionally, the J&J Janssen vaccine “can it is in stored at consistent refrigerator temperatures and also does not need dilution, which makes storage and management easier,” Dr. Fryhofer explained. “Many clinicians had high wishes of using this vaccine in hard to with geographical areas. We need this vaccine as an option.”

There room three for sure vaccines

There are three safe vaccines

“Don’t get recorded up necessarily on the numbers game, since it’s a safe and also effective vaccine and what we need is to have as many effective vaccines as possible,” stated Dr. Irons. Rather than focusing on efficacy rates, “accept the truth that currently you have three highly reliable vaccines.”

“We do have actually three safe and highly efficient COVID vaccines. COVID vaccines continue to preserve high protection versus severe disease, hospitalization and also death,” said Dr. Fryhofer. “However, we room seeing breakthrough infections. That all about waning immunity—with time and also with the Delta variant, together with concern about vaccine effectiveness versus future variants of concern.

“Studies presented to FDA and also others the evaluation by ACIP show some waning that immunity with time,” she added. “For example, a current study released in Sept. 28 MMWR looked at COVID vaccine effectiveness versus hospitalization native mid-March through mid-August. VE—vaccine effectiveness—was greater for Moderna vaccine at 93% as contrasted to Pfizer-BioNTech vaccine at 88%.”

“Pfizer vaccine effectiveness declined considerably from 91% down to 77%—at more than four months after the second vaccine dose. Moderna vaccine effectiveness did not wane as lot as Pfizer,” Dr. Fryhofer explained. “VE because that both mRNA vaccines was higher than Janssen. Janssen’s single dose vaccine had the lowest vaccine efficiency at 71%.

“Janssen security is nice stable—it no wane together much, however its vaccine effectiveness has never ever been as much as par through mRNA vaccines,” she added. “Janssen never ever made it approximately mRNA vaccine standards when it pertained to vaccine effectiveness, so the booster recommendation for anyone who obtained Janssen should aid enhance the protection.”

Read about what come tell your patients as soon as they ask i beg your pardon vaccine come get.

Everyone should acquire a booster shot

Everyone should get a booster shot

“For adult who get the Janssen vaccine, the time frame"s different” 보다 booster shots for Pfizer-BioNTech and also Moderna mRNA vaccines, explained Dr. Fryhofer throughout an episode of the “AMA COVID-19 Update” about the new mix and match strategy because that boosters. “A booster is encourage at the very least two month after a solitary Janssen dose major series. This applies to everyone 18 and older who got it.

“This large eligibility is because of Janssen"s reduced vaccine effectiveness as contrasted to mRNA vaccines. The rise can help increase Janssen vaccine effectiveness,” she added. “And to get a booster, it"s tho the honor system. If human being say they"re eligible, castle can obtain it.”

For side results from the booster shot, “people need to expect more of the same—pain in ~ the injection site, headache, fatigue, muscle aches, fever, chills,” said Dr. Fryhofer, adding that side effects “probably won"t it is in worse v one exception, tender swollen lymph nodes under the vaccinated arm.”

Additionally, “risk the vaccine-specific adverse reactions in certain age groups, and also sex-based differences might be considered,” she said. “For example, Janssen vaccine has been connected to TTS—thrombosis v thrombocytopenia syndrome—in i m sorry rare varieties of blood coagulation in inexplicable places together with really short platelets.

“The TTS danger is higher in females under 50 and also this is why some ACIP members to be concerned about young women receiving a second Janssen vaccine dose and also push because that the nonspecific language for the sort of booster allowed,” Dr. Fryhofer added, additionally noting the “Guillain Barré Syndrome, GBS, hazard is highest in males 50-64, in the 42-day window after the an initial dose.”

Discover what doctors have to know about Moderna and J&J COVID-19 vaccine boosters.

Mixing and matching is OK

Mixing and also matching is OK

“The language CDC provides in the reference for the sort of booster to offer is neutral and vague. … the doesn"t clues what kind of booster come give, and also this is not an oversight,” stated Dr. Fryhofer. “The bottom line: you can rise with any type of authorized COVID vaccine.

“The booster doesn’t have to enhance the primary vaccine series type. This is called heterologous boosting,” she added. “On the other hand, raising with the same form of vaccine as the one you originally received is dubbed homologous boosting. Either strategy is permitted.”

The “CDC and also FDA action quickly and also issued a share statement recommending the pause,” Dr. Fryhofer said during a current “AMA COVID-19 Update” episode around the J&J Janssen COVID-19 vaccine pause. The CDC likewise “released extr information v its health and wellness Alert Network,” i beg your pardon “could command to an ext cases gift reported together a an outcome of enhanced awareness.”

Additionally, the CDC warned “that in these cases, heparin, a standard therapy for blood clots, could cause tremendous harm,” Dr. Fryhofer added, noting that the “CDC advises checking because that platelet activating antibodies by doing a platelet element four (PL4) antibody test.”

The “CDC advises against heparin therapy if platelet factor four antibody check is positive,” she said. “If PL4 check is positive, usage of non-heparin anticoagulants and also high sheep intravenous immune globulin have to be considered. Hematology consultation is likewise advised.”

After a thoroughly review, ACIP lifted the J&J Janssen vaccine stop April 23.

AMA chairman Susan R. Bailey, MD, commended ACIP because that “reaffirming its referral on the usage of the Janssen COVID-19 vaccine” for those 18 or older under the FDA’s emergency usage authorization. “The population-level data presented throughout ACIP’s conference … plainly demonstrates that the services of this strategy outweigh the risks,” she said.

“The stop on the Janssen COVID-19 vaccine has demonstrated the toughness of our nation’s vaccine security monitoring system and the transparent and also careful deliberations by the ACIP must raise to trust in FDA-authorized and also CDC-recommended COVID-19 vaccines,” Dr. Bailey added. “The AMA continues to encourage everyone that is eligible because that COVID-19 vaccines to gain vaccinated as quickly as possible.”

Discover what physicians should know about the J&J vaccine and brain blood clots.

Which symptom to watch for

Which symptom to look at for

“After COVID vaccination, patients must expect flu-like symptoms, a mild to moderate headache, fatigue, fever, muscle aches,” Dr. Fryhofer said, noting that “these symptoms room expected and also usually settle within one to 2 days.”

There is additionally risk that a rare brain blood clot combined with low platelets—cerebral venous sinus thrombosis v thrombocytopenia, or TTS. These adverse events were established through the Vaccine Adverse occasion Reporting System, i m sorry is jointly controlled by the CDC and also FDA. The greatest reporting rate is in 30–39-year-old females within 21 days of vaccination and occurs in ~ a price of 10 situations per million doses administered.

“The danger of this concerning mix of blood clots and low platelets is rare but serious,” she said. “Patients who’ve had the Janssen vaccine must seek instant medical attention if they build shortness that breath, chest pain, foot swelling, persistent ab pain, neurological symptoms including severe or persistent headache or blurred vision, or petechiae beyond the website of vaccination.

“Patients v these symptoms should call their physician and seek medical evaluation,” Dr. Fryhofer added.

Additionally, the FDA updated the reality sheet (PDF) for the J&J COVID-19 vaccine and included Guillain Barré Syndrome—a rarely disorder the occurs as soon as a person’s immune mechanism damages nerve cells and also causes muscle weak or paralysis—as a danger of the vaccine. The chance of having actually this take place is an extremely low and the benefits of the vaccine outweigh the risks. Many cases developed in males 50 and older about two weeks ~ J&J vaccination with enhanced risk throughout the 42-day home window after vaccination.

Patients should seek medical care if they construct weakness or tingling sensations in the foot or arms that worsens and also spreads to other parts the the body. Other symptoms come be mindful of are difficulty with walking, facial movements and bladder manage or bowel function as fine as double vision or i can not qualify to move their eyes.

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You have other vaccine choices

You have other vaccine choices

The FDA updated the J&J Janssen vaccine EUA (PDF) with second warning, noting that “women under 50 need to be made aware of a rare danger of blood clots and low platelets following vaccination,” stated Dr. Fryhofer. “They likewise need to understand there are other COVID vaccines the end there that don’t posture this small risk.

“That empowers patient choice. The also means vaccination clinics have to make clean which vaccine or vaccines space being offered and also when,” she added.

With the J&J Janssen vaccine, the benefits of the one-dose regimen far outweigh the risks. But, if human being are worried, they can accessibility Pfizer or Moderna COVID-19 vaccines. There have been an ext than 180 million sheep of mRNA vaccines by Pfizer and Moderna administered v no reports the cerebral venous sinus thrombosis with thrombocytopenia.

Discover what to tell her patients once they ask i m sorry COVID-19 vaccine they should get.

Adenovirus vector vaccines no new

Adenovirus vector vaccines no new

“Janssen’s phase 3 clinical psychological included much more than 40,000 participants. In addition, Janssen’s viral vector communication is supported by an also larger body of evidence, including an Ebola vaccine that"s already been experiment in pregnant women and also children and also approved in Europe,” stated Dr. Fryhofer. “More than 193,000 people—including patients of various ages and also conditions—have been vaccinated with miscellaneous investigational vaccines utilizing this adenovirus platform.”

“The adenovirus vector vaccine offers a amendment cold virus—an adenovirus dubbed Ad26—as the viral vector and several genes have been gotten rid of from this virus,” she explained. “It’s replication deficient, so it cannot multiply in the body.”

This means that “it cannot provide someone COVID-19,” said Dr. Fryhofer. “The agency says this security sign imbalance—blood clots and also low platelets—did not show up in the phase 3 trial or with their research on other Ad26 based famous vector vaccines.

“However, in the phase 3 trial, one patient, a 25-year-old male, did endure CVST, had actually low platelets and likewise had PF4 antibodies,” she added.

Expect the very same side effects

Expect the very same side effects

Aside from the exceptionally rare blood clots and also risk that GBS debated above, “the side effects for the J&J vaccine are very similar to those because that the mRNA vaccines, including injection-site pain, headache, fatigue, fever, chills and muscle aches,” said Dr. Fryhofer.

With most of the next effects occurring within one to two days following vaccination, Dr. Fryhofer recommends picking a day or two as soon as “you don’t have actually a many of essential stuff going on, because you could not feeling well.”

Learn an ext from the AMA around what medical professionals wish patient knew around COVID-19 vaccination.

There is simpler access

There is much easier access

Since the J&J vaccine no require colder temperatures for storage together the Moderna and Pfizer vaccines do, “it’s an ext mobile, therefore it’s perfect for world who room homebound, that can’t—or won’t—go come a 2nd appointment,” said Dr. Fryhofer. “It’s also great for world who move approximately a lot.”

“As i have talked to other physicians around this vaccine, one doctor who provides health treatment for those in jails and also prisons said, ‘We have people constantly coming in and out that the system, it’s difficult keeping track,’” she said. “So, this is one way we can give castle this vaccine and also feel an excellent that lock now completely vaccinated. CDC’s mix and match booster strategy boosts the versatility of keeping people protected.”

Tested in large, varied groups

Tested in large, diverse groups

As v the Moderna and also Pfizer COVID-19 vaccine trials, the J&J vaccine was tested with in large and varied populations the patients. Practically 44,000 human being in south Africa, particular countries in southern America, Mexico and also the U.S. Took component in the J&J testing.

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“These vaccine manufacturers, when they’ve recruited participants, they’re thinking around diversity,” stated Dr. Fryhofer. “They’re including human being with various ethnicities and also different geographies. They additionally include both older and younger people as well as those v underlying clinical conditions.”

The AMA has occurred frequently-asked-questions documents on COVID-19 vaccination spanning safety, allocation and also distribution, administration and more. There space two FAQs, one designed to answer patients’ questions (PDF), and also another to resolve physicians’ COVID-19 vaccine concerns (PDF).

Table that Contents

Table of contents One sheep is a complete vaccine collection There space three safe vaccines everyone should get a booster shoot Mixing and also matching is yes Vaccine pause showed system’s strength Which symptoms to look for You have actually other vaccine options Adenovirus vector vaccines aren’t brand-new Expect the exact same side results There is easier access Tested in large, diverse groups