Vaccine Pause Showed Systems Strength
The CDC and FDA acted quickly and issued a joint statement recommending the pause, Dr. Fryhofer said during a recent AMA COVID-19 Update episode about the J& J Janssen COVID-19 vaccine pause. The CDC also released additional information through its Health Alert Network, which could lead to more cases being reported as a result of increased 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 for platelet activating antibodies by doing a platelet factor four antibody test.
The CDC advises against heparin therapy if platelet factor four antibody test is positive, she said. If PL4 test is positive, use of non-heparin anticoagulants and high dose intravenous immune globulin should be considered. Hematology consultation is also advised.
After a thorough review, ACIP lifted the J& J Janssen vaccine pause April 23.
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 FDAs emergency use authorization. The population-level data presented during ACIPs meeting clearly demonstrates that the benefits of this approach outweigh the risks, she said.
Adenovirus Vector Vaccines Arent New
Janssens phase three clinical trial included more than 40,000 participants. In addition, Janssens viral vector platform is supported by an even larger body of evidence, including an Ebola vaccine that’s already been tested in pregnant women and children and approved in Europe, said Dr. Fryhofer. More than 193,000 peopleincluding patients of different ages and conditionshave been vaccinated with various investigational vaccines using this adenovirus platform.
The adenovirus vector vaccine uses a modified cold virusan adenovirus called Ad26as the viral vector and several genes have been removed from this virus, she explained. Its replication deficient, so it cannot multiply in the body.
This means that it cannot give someone COVID-19, said Dr. Fryhofer. The company says this safety sign imbalanceblood clots and low plateletsdid not show up in the phase three trial or with their research on other Ad26 based viral vector vaccines.
However, in the phase 3 trial, one patient, a 25-year-old male, did suffer CVST, had low platelets and also had PF4 antibodies, she added.
Which Symptoms To Look For
After COVID vaccination, patients should expect flu-like symptoms, a mild to moderate headache, fatigue, fever, muscle aches, Dr. Fryhofer said, noting that these symptoms are expected and usually resolve within one to two days.
There is also risk of a rare brain blood clot combined with low plateletscerebral venous sinus thrombosis with thrombocytopenia, or TTS. These adverse events were identified through the Vaccine Adverse Event Reporting System, which is jointly managed by the CDC and FDA. The highest reporting rate is in 3039-year-old females within 21 days of vaccination and occurs at a rate of 10 cases per million doses administered.
The risk of this concerning combination of blood clots and low platelets is rare but serious, she said. Patients whove had the Janssen vaccine should seek immediate medical attention 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.
Patients with these symptoms should contact their physician and seek medical evaluation, Dr. Fryhofer added.
Patients should seek medical care if they develop weakness or tingling sensations in the legs or arms that worsens and spreads to other parts of the body. Other symptoms to be mindful of are difficulty with walking, facial movements and bladder control or bowel function as well as double vision or inability to move their eyes.
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There Is Easier Access
Since the J& J vaccine doesnt require colder temperatures for storage as the Moderna and Pfizer vaccines do, its more mobile, so its perfect for people who are homebound, that cantor wontgo to a second appointment, said Dr. Fryhofer. Its also good for people who move around a lot.
As Ive talked to other physicians about this vaccine, one physician who provides health care for those in jails and prisons said, We have people constantly coming in and out of the system, its hard keeping track, she said. So, this is one way we could give them this vaccine and feel good that theyre now fully vaccinated. CDCs mix and match booster strategy enhances the flexibility of keeping people protected.
Why Did The Cdc Recommend The Mrna Vaccines Over J& j
In December, the CDC recommended a preference for the two mRNA vaccines over J& J in response to concerns that had been building over a small, but growing number of cases of a rare, but serious clotting disorder in people whod gotten the shot. In April 2021, the agency put a two-week pause on the vaccine while the matter was investigated. The pause was then lifted, but concern grew as more cases were reported.
The clotting disorder is called thrombosis with thrombocytopenia syndrome , and it is rarein 17 million people who got J& J, 54 cases of TTS were reported, 36 of those people were cared for in an intensive care unit, and nine people died . The Food and Drug Administration updated its fact sheet on the shot.
The FDA also attached a warning to the J& J vaccine in July, after reports linked the vaccine to Guillain-Barré syndrome, a rare neurological disorder. For both warnings, the agency said the incidence was very rare, and the benefits of the vaccine still outweighed the risks.
All three vaccines available in the United States have had reports of rare adverse events. The FDA added warnings to the Pfizer and Moderna vaccines following reports of rare cases of myocarditis and pericarditis after mRNA vaccination, particularly in male adolescents and young adults.
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What Are The Side Effects Of The Johnson & Johnson Covid
The vaccine was generally well-tolerated in study participants, Johnson & Johnson said in a press release. According to the data so far, the vaccine may cause mild-to-moderate side effects typically associated with vaccinations, similar to those expected from the Pfizer and Moderna vaccines. This includes cold-like symptoms, like a headache, body aches, pain at the injection site, and a fevera normal sign that the bodys immune response is being primed.
TTS, a very rare side effect of the vaccine, is more serious. Again, its a condition that causes blood clotting and low plate counts, which could turn deadly out of 54 confirmed cases, nine of those patients died. TTS is most common in women between 30 and 49 years old the condition appears in about one in 100,000 women in those age groups who receive Johnson & Johnson, per the CDC.
Because of this rare condition, the CDC now recommends Pfizer and Moderna over Johnson & Johnson. The CDC and the FDA recommend that anyone who received the Johnson & Johnson vaccine monitor for severe headache, abdominal pain, leg pain, and shortness of breath within three weeks of vaccination. If these symptoms develop, contact your healthcare provider for proper diagnosis and treatment.
To be clear, the experts agree that the vaccines are the best way to protect yourself and your loved ones amid a new surge of COVID-19and this time, both patients and doctors are more aware of the slight risks involved.
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There seems to be little guidance now for recipients of the least-used vaccine. So if youve already gotten the J& J shot or are still considering it, whats the latest on the protection it provides and whether you need more shots?
TODAY asked Dr. Daniel Kuritzkes, chief of the division of infectious diseases at Brigham and Womens Hospital in Boston and professor of medicine at Harvard Medical School and Dr. Roy Gulick, chief of the division of infectious diseases at NewYork-Presbyterian/Weill Cornell Medical Center and professor of medicine at Weill Cornell Medicine.
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Are There Persons For Whom The Vaccine Is Contraindicated
Persons who are allergic to any of the vaccines ingredients, or who have had an allergic reaction to a similar vaccine in the past should avoid the vaccine. To learn more about rare allergic reactions, see here. If you are pregnant or have questions about the vaccine and your personal health concerns, please consult with your provider prior to vaccination.
Latest News On The Johnson & Johnson Vaccine
Until now, the U.S. has treated all three COVID-19 vaccines available to Americans as an equal choice, since large studies found they all offered strong protection and early supplies were limited.
J& J’s vaccine initially was welcomed as a single-dose option that could be especially important for hard-to-reach groups who might not get the needed second dose of the Pfizer or Moderna options.
However, people who received the single-dose vaccine were then encouraged by health officials to receive a second dose of the J& J vaccine at least two months after their initial dose to bring their protection up to the same level as those who received two-dose vaccines.
Now, the CDC prefers Americans over the age of 18 get an mRNA booster, as studies showed those vaccines provide more protection against COVID-19 and more cases of blood clots were reported in people who got the J& J vaccine.
Out of approximately 17 million people in the United States who have gotten the J& J vaccine, there have been 54 cases of the condition called thrombosis with thrombocytopenia and nine deaths.
“This is not a failure of our system, this is actually a success of the very rigorous vaccine safety monitoring and evaluation we have in the U.S.,” said Dr. Bill Moss, executive director of the International Vaccine Access Center at the Johns Hopkins Coronavirus Resource Center. “This is really our safety system at work.”
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Summary Of Cdc And Fda Recommendations
The CDC and FDA include the following findings in their recommendations to resume administration of the Johnson & Johnson/Janssen vaccine:
- As of April 23, 2021, more than 8 million doses of the J& J/Janssen COVID-19 vaccine have been given in the United States. Experts reviewing safety reports for this vaccine found a small number of women who got the J& J vaccine and later developed thrombosis with thrombocytopenia syndrome . TTS is a serious condition that involves blood clots with low platelets.
- Nearly all reports of this serious condition have been in adult women younger than age 50.
- The risk of this adverse event is rare, occurring at a rate of about 7 per 1 million vaccinated women between 18 and 49 years old. For women 50 years and older and men of all ages, this adverse event is even rarer.
- A review of all available data at this time shows that this vaccines known and potential benefits outweigh its known and potential risks.
- However, women younger than age 50 should be aware of this rare adverse event and should know that other COVID-19 vaccines are available.
Read the full CDC recommendations to resume use of the J& J vaccine.
Expect The Same Side Effects
Aside from the extremely rare blood clots and risk of GBS discussed above, the side effects for the J& J vaccine are very similar to those for the mRNA vaccines, including injection-site pain, headache, fatigue, fever, chills and muscle aches, said Dr. Fryhofer.
With most of the side effects occurring within one to two days following vaccination, Dr. Fryhofer recommends choosing a day or two when you dont have a lot of important stuff going on, because you might not feel well.
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Are You Still Considered Fully Vaccinated With One J& j Shot
Yes, a person who has received a primary series of a COVID-19 vaccine a single-dose, in the case of J& Js vaccine is considered fully vaccinated, according to the CDC.
I think thats in sore need of updating, Kuritzkes said. Practically speaking, based on the totality of the data, I would consider that a single shot of the J& J vaccine is inadequate to provide full protection.
The CDC is now moving towards the terminology of staying up to date with your vaccines, which means additional shots.
How Did J& j Boosters Get Authorized For Use
Early in 2021, when Johnson & Johnson’s vaccine was authorized for use in the United States, some people expressed concern about the efficacy of the single-shot vaccine, which trailed behind the Pfizer and Moderna vaccines, based on data from their clinical trials at that time.
Later in the year, in early October, the CDC approved the Johnson & Johnson booster after the company shared dataincluding 94% efficacy against symptomatic disease after a boosterthat put its vaccine on par with the mRNA COVID-19 vaccines from Pfizer-BioNTech and Moderna.
Initially the two mRNA vaccines were available only to certain at-risk populations, but that was later revised so that anyone who had gotten the primary dose of one of the three vaccines was eligible for a booster.
Still, far more people in the U.S. got vaccinated with the Pfizer or Moderna vaccines. As of December 2021, about 16 million Americans were fully vaccinated with the J& J vaccine, compared to more than 73 million who received Moderna and 114 million who received Pfizer, according to the CDC.
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Effectiveness Against The Delta Variant
There is currently limited data available showing how effective the vaccine is at protecting against the Delta variant.
According to information released by Johnson & Johnson, the vaccine was found be 85% effective against severe/critical disease from COVID-19, including that caused by the Delta variant. Data from a clinical study published in The New England Journal of Medicine also supports this finding.
In December 2021 the Centers for Disease Control and Prevention endorsed updated recommendations made by the Advisory Committee on Immunization Practices for the prevention of COVID-19, expressing a clinical preference for individuals to receive an mRNA COVID-19 vaccine over Johnson & Johnsons COVID-19 vaccine.
This updated CDC recommendation follows similar recommendations from other countries, including Canada and the United Kingdom, said the CDC. Given the current state of the pandemic both here and around the world, the ACIP reaffirmed that receiving any vaccine is better than being unvaccinated.
Results from the Sisonke trial, which examined 480,000 South African health workers who received the one-dose vaccine, suggest that it is up to 95% effective in preventing death from the Delta variant and up to 71% effective against hospitalization. Although promising, this new data from the trial has yet to be peer-reviewed or published in a scientific journal.
When Will It Be Available
The Johnson & Johnson vaccine was granted emergency use authorization from the FDA for its single-dose vaccine. As of April 28, 2021, Johnson & Johnson has supplied 17.6 million doses to the U.S. and more than 8 million people have received the vaccine, according to the CDC.
In August 2020, Johnson & Johnson announced it had a contract with the U.S. government for 100 million doses and the option to purchase an additional 200 million doses. In March 2021, President Biden announced plans to purchase an additional 100 million doses, bringing the total to 200 million doses.
The U.S. government announced a partnership with Merck to help accelerate the production of the Johnson & Johnson vaccine. Merck will receive up to $268.8 million from the Biomedical Advanced Research and Development Authority to adapt and make available its manufacturing facilities for producing the Johnson & Johnson COVID-19 vaccine.
COVID-19 Vaccines:Stay up to date on which vaccines are available, who can get them, and how safe they are.
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Vaccine Review Approval And Monitoring
Health Canada’s independent drug review and approval process is recognized around the world for its high standards and rigor. Our decisions are based only on scientific and medical evidence showing that vaccines are safe and effective. The benefits must also outweigh any risks.
The Janssen COVID-19 vaccine was authorized for use in Canada under the Interim Order respecting the importation, sale and advertising of drugs for use in relation to COVID-19. On November 23, 2021, Janssen COVID-19 vaccine transitioned to an authorization under the Food and Drug Regulations.
Find detailed technical information such as the product monograph and the regulatory decision summary:
As COVID-19 vaccines are administered across Canada, our safety monitoring is ongoing. The Public Health Agency of Canada, Health Canada, and provincial and territorial health authorities continue to:
- monitor the use of all COVID-19 vaccines closely
- examine and assess any new safety concerns
How Long After Getting The J& j Vaccine Can Blood Clots Occur
This condition can occur four to 42 days after vaccination.
Symptoms may include a severe headache, visual changes, abdominal pain, nausea and vomiting, back pain, shortness of breath, leg pain or swelling, the appearance of round brown-purple spots, easy bruising, or bleeding, according to the American Society of Hematology.
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How Effective Is One Dose Of The Johnson & Johnson Vaccine
Early clinical trial data released in January 2021 showed that four weeks after the first dose, the Johnson & Johnson singleshot vaccine was 66.3% effective at preventing COVID-19 infection. The initial studies also showed that it was 85% effective at preventing severe or critical disease.
But the original clinical trials and most subsequent studies were done before the delta variant became responsible for almost all of the COVID-19 cases in the U.S. Early studies suggest that although COVID-19 vaccines are still effective against this variant, in general their efficacy is lower compared to protection against the original strain.
On Sept. 21, 2021, Johnson and Johnson announced the results of a large, real-world Phase 3 clinical trail of their COVID-19 vaccine. This study collected data from March 1, 2020 through July 31, 2021 and found that the effectiveness of the vaccine did not diminish over the duration of the study, even after the Delta variant became dominant in the U.S. The one-dose vaccine was 79% protective against COVID-19 infections and 81% protective for COVID-19-related hospitalizations. This indicates that a single Johnson & Johnson shot performs well, even in the presence of Delta and other variants.