Does The Vaccine Have Side Effects
In some persons, yes. Included among the symptoms are swelling at the injection site, headache, joint and muscle pain, fever, fatigue, and nausea. The side effects are usually transient and mild, and can be taken as evidence that the vaccine is working to create an immune response. Severe side effects, such as allergic reactions, are rare.
The vaccine was temporarily paused in April 2021 for further analysis of blood clotting concerns. Women under the age of 50 should be aware of the risk of a rare blood clotting syndrome associated with the vaccine. If you are concerned about a possible allergic or severe reaction, please consult with your medical provider prior to receiving the vaccine.
Variants Were Spreading During Testing
When it came time for the Janssen vaccine trial, the background COVID incidence was higher, said Dr. Fryhofer. There were more variants circulating, including the variants of concern that can increase transmissibility and disease severity.
When the Janssen vaccine was tested, it was at the height of the pandemic, she said. The variants of concern were out there, so the test for the Janssen vaccine was harderyou cant compare them.
If you look at the Janssen vaccine, the efficacy did vary across geographic regions, said Dr. Fryhofer. In the United States, it was 74.4% effective. In South Africa, it was only 52% effective and thats where that variant B.1.351 was dominant.
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 protected.
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Vaccine Safety & Side Effects
Check out Immunize Alberta for Common Questions about Vaccine Safety.
Q: What goes into making sure vaccines, including the COVID-19 vaccines, are safe and effective?
A: Canada is recognized around the world for high standards for vaccine review, approvals, and monitoring systems. Only vaccines that are safe and effective will be approved for use in Canada. After a vaccine is approved for use, evidence on safety and effectiveness is reviewed by the National Advisory Committee on Immunization who provide recommendations on immunizations for individuals and for public health programs.
Q: Have there been any adverse events following immunization with the COVID-19 vaccine?
A: Health Canada, the Public Health Agency of Canada , the provinces and territories, and manufacturers continue to closely monitor the safety of COVID-19 vaccines and respond to any safety issues that arise.
Provincially the Government of Alberta has the most up-to-date figures on adverse events following immunization with the COVID-19 vaccine. A weekly report on side effects following COVID-19 vaccination in Canada, is available from the Government of Canada.
The benefits of vaccines authorized in Canada continue to outweigh the risks. All eligible Albertans born in 2009 or before are encouraged to get immunized as soon as possible.
Q: I am experiencing side-effects from the COVID-19 vaccine, what do I do?
Q: What should I know about myocarditis and pericarditis following COVID-19 vaccinationes?
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.
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What If I’m Immunocompromised And Got J& j
Immunocompromised people who received Johnson & Johnson and are “moderately or severely immunocompromised” should get a booster of any COVID-19 vaccine at least two months after the single dose. This is the same recommendation for everyone else who got Johnson & Johnson, but given that people with a suppressed immune system usually aren’t able to mount as strong an immune response, it may be especially important they seek out a second dose of COVID-19 vaccine.
Although very few immunocompromised people likely received Johnson & Johnson compared to Moderna or Pfizer, a CDC committee member said, those who did were neglected in the CDC’s initial recommendation for an extra dose for moderately or severely immunocompromised folks for lack of data. This week, the CDC issued guidance that Moderna or Pfizer recipients who are moderately or severely immunocompromised may receive a fourth shot or booster at least six months after their third shot.
Dont Compare The Three Vaccines
Dont get caught up necessarily on the numbers game, because its a safe and effective vaccine and what we need is to have as many effective vaccines as possible, said Dr. Irons. Rather than focusing on efficacy rates, accept the fact that now you have three highly effective vaccines.
These vaccines have not been tested head to head, so its impossible to do a really accurate comparison, she said. What matters most is they are all effective at preventing the most severe COVID outcomes, including hospitalization and death.
All three vaccines far exceeded FDAs 50% efficacy threshold, said Dr. Fryhofer.
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Do Johnson & Johnson Recipients Need A Booster Shot
Some worry that giving boosters to people in wealthy nations will waste precious doses that could be given to unvaccinated people in poorer countries. To prevent this, the World Health Organization called for a moratorium on boosters until at least the end of September.
On Aug. 25, 2021, Johnson & Johnson announced that people who initially received a single shot vaccine and then received the same shot as a booster produced a much stronger antibody response than after receiving a single dose. This new study provides data to support a booster for those who received the single-dose Johnson & Johnson vaccine despite the larger controversy and uncertainty.
On Aug. 22, 2021, U.S. Surgeon General Dr. Vivek Murthy said that Johnson & Johnson recipients will likely need a booster. The government needs more information before making a recommendation about the need for a booster shot, and since the vaccine was rolled out three months after the mRNA vaccines, key studies are still in progress.
Coronavirus Vaccine At Publix Pharmacy
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Gbs Typically Develops After An Infection Not A Vaccine
It is much more common to get GBS from an infection than from a vaccination, Dr. Levin explains.
Each year in the U.S., an estimated 3,000 to 6,000 people develop GBS, typically triggered by a viral or bacterial infection, including the flu or even COVID-19.
Thats right: Dr. Levin says there are examples of people developing GBS immediately following infection with COVID-19.
Who Can Get Boosters And When
Immunity from the Pfizer-BioNTech or Moderna COVID-19 vaccine starts to wane six months after the initial dose.
- You are 65 and older.
- You are 18 and over, have an underlying medical condition or work in a high-risk setting.
Workers at increased risk of contracting COVID-19 include first responders, teachers, daycare workers, U.S. Postal Service employees, public transit staff, grocery store employees, food and agriculture workers and corrections workers, according to the CDC.
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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.
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
Johnson & Johnson Vaccine And Covid
Recent news has continued to discuss the need for ongoing vigilance because of the significance of the emerging COVID-19 variants. While Pfizer and Moderna vaccines have not been fully studied against the variants, the Johnson & Johnson vaccine clinical trials were conducted in South Africa and Brazil when the new variants had become prevalent. In South Africa, approximately 95 percent of the circulating virus was the B.1.351 variant and in Brazil, roughly 69 percent of the circulating virus was a P1/P2 variant at the time of the trial.
While the overall efficacy of the Johnson & Johnson vaccine is significantly lower, it is known to protect against the variants that are now being seen in the United States. Individuals who receive or already received the Pfizer or Moderna vaccine may have to receive a booster shot to protect themselves against the new variants. Current development is underway for those booster vaccines.
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What We Know So Far
Pausing the Johnson & Johnson vaccine was a response to the six cases reported in late March and early April to the Vaccine Adverse Events Reporting System , a national early reporting warning system to detect safety problems with U.S.-licensed vaccines. All six people were women aged 1848 years who experienced onset of symptoms between 613 days.
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.
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.
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Does It Have To Be Another Shot Of J& j
No. You can get any of the three COVID-19 vaccines available, meaning your choice can depend on your personal circumstances or preference. Both Johnson & Johnson’s and Pfizer’s boosters are the same dosage as the original series, while Moderna’s booster is a smaller dose than its original series.
However, some committee members expressed concerns over recommending a second dose of Johnson & Johnson to women under age 50, who are at a higher risk for the very rare but also very serious blood clotting disorder associated with the vaccine .
Importantly, this risk isn’t associated with the Pfizer or Moderna vaccines. There is also the rare risk of a neurological disorder linked to Johnson & Johnson, occurring mostly in older men. In clinical guidance issued this week, meant to help walk eligible adults through choosing a booster dose, the CDC said that patients with a history of Guillain-Barré syndrome should “discuss the availability of mRNA COVID-19 vaccines” for protection against the coronavirus. The CDC also issued guidance that women under age 50 “should be made aware of the rare risk of TTS after receipt of the Janssen COVID-19 vaccine and the availability of other currently FDA-approved or FDA-authorized COVID-19 vaccines.”
CDC committee member Dr. Pablo Sanchez, said that while he agrees people who received Johnson & Johnson should get a second dose, “I would prefer that those individuals get an mRNA vaccine,” he said.
Blood Clots Are Also A Complication Of Covid
Researchers have also seen a strong association between blood clots and COVID-19 infection itself, says Hyung Chun, MD, a Yale Medicine cardiologist. Unfortunately, in those who are sick enough with COVID-19 to be in the intensive care unit , blood clots have been a major factor in their illness, Dr. Chun says. Close to 20% of COVID-19 patients in the ICU develop blood clots, he says. Thats far higher than what youd expect for patients who are in the ICU for different conditions. Estimates Ive seen are in the 3 to 10% range for patients admitted for other reasons,” adds Dr. Chun.
COVID-19 infection seems to cause the blood vessels and the blood itself to behave in a way that promotes formation of blood clots, which is likely a key driver for poor outcomes, sometimes damaging vital organs and even leading to death, Dr. Chun says.
Dr. Chun and colleagues published a study in The Lancet Haematology after identifying a leading mechanism behind blood clots in COVID-19 patients. Yale Medicine hematologist Alfred Lee, MD, PhD, and George Goshua, MD, a hematology-oncology fellow, were also authors of the study. They found that endothelial cells play a surprising role in the formation of blood clots, especially as a COVID-19 patient becomes critically ill. They hope the finding will eventually contribute to determining treatment for the blood clots. So far, there is not a clear-cut answer, Dr. Chun says.
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What Should You Know About The Fda Warning Labels Attached To J& js Vaccine
All three vaccines available in the United States have had their setbacks, including reports of adverse events, but these have been rare. 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.
For people who got Johnson & Johnson, the FDA has added two warnings to the vaccine. The first was this past April, after the vaccination was linked to a small number of cases of an uncommon, but potentially serious blood clotting disorder, prompting the agency to put a two-week pause on the vaccine while the issue was investigated. The second was in July, after reports linked the vaccine to Guillain-Barré syndrome, a rare neurological disorder. In both cases, the agency said the incidence was very rare, and the benefits of the vaccine still outweighed the risks.
Should Pregnant Women Be Vaccinated
WHO recommends the use of the COVID-19 vaccine in pregnant women only if the benefits of vaccination to the pregnant woman outweigh the potential risks. To help pregnant women make this assessment, they should be provided with information about the risks of COVID-19 in pregnancy, the likely benefits of vaccination in the local epidemiological context, and the current limitations of safety data in pregnant women. WHO does not recommend pregnancy testing prior to vaccination. WHO does not recommend delaying pregnancy or terminating pregnancy because of vaccination. While pregnancy puts women at higher risk of severe COVID-19, very little data are available to assess vaccine safety in pregnancy.
Who is the vaccine not recommended for?
Individuals with a history of anaphylaxis to any component of the vaccine should not take it.
Anyone with a body temperature over 38.5ºC should postpone vaccination until they no longer have a fever.
The vaccine is not recommended for persons younger than 18 years of age pending the results of further studies in that age group.
Whats the recommended dosage?
SAGE recommends the use of Janssen Ad26.CoV2.S as one dose given intramuscularly.
There should be a minimum interval of 14 days between the administration of this vaccine and any other vaccine against other health conditions. This recommendation may be amended as data on co-administration with other vaccines become available.
Is it safe?
How efficacious is the vaccine?
Very common > 1/10
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Will The J& j Booster Be Available To Everyone
The FDA advisory panel is recommending Johnson & Johnsons booster be given to all adults ages 18 and older who got the single shot. The booster would be given as soon as two months after the initial dose.
This broad recommendation for the J& J booster is in contrast to the specific recipient recommendations for the Pfizer booster, which was authorized in September. The CDC recommended the Pfizer booster only for people ages 65 and up, residents of long-term care settings, and people ages 18 to 64 with underlying medical conditions or whose work may put them at higher risk of exposure to COVID-19. The recommendation was for the booster shot to be given 6 months after the second Pfizer dose.
In October, the FDA made a similar booster recommendationin terms of who should receive itfor Moderna. The Moderna booster is a reduced dose to be given at least 6 months after the second Moderna shot.
Jaimie Meyer, MD, MS, a Yale Medicine infectious diseases physician, says its important to remember that authorizing boosters for everyone might not be the best strategy. Boosters don’t work equally as well across an entire population, she says. There are certain groups of people who stand to benefit more from boosters than others, in terms of the overall public health approach to the pandemic, either because they’re at very high risk of severe diseaseor because of exposure.