One Dose Is A Full Vaccine Series
The J& J vaccine is the first authorized vaccine to require one dose instead of two, said Dr. Irons during an episode of the AMA COVID-19 Update about the .
A Janssen vaccine series is still a single dose of vaccine thats designated in Janssens emergency use authorization from FDA, said Dr. Fryhofer, a member of the AMA Board of Trustees. One dose is still considered a full dose series for public health purposes, but now a booster is recommended at least two months later for everyone 18 and older who has received a single Janssen dose.
Some experts say Janssen should have been a two-dose vaccine from the beginning, she added. When and if Janssen receives full FDA approval, the one dose recommendation could change and possibly become two, but that has not happened yet and it may not. It will be interesting to see what happens.
Additionally, the J& J Janssen vaccine can be stored at regular refrigerator temperatures and does not require dilution, which makes storage and administration easier, Dr. Fryhofer explained. Many clinicians had high hopes of using this vaccine in hard to reach geographical areas. We need this vaccine as an option.
Q: Why Did The Fda And Cdc Recommend A Pause In The Use Of The Janssen Covid
A: As a result of ongoing safety monitoring, on April 13, 2021, the FDA and CDC recommended a temporary pause in the use of Janssen COVID-19 Vaccine, due to reports of a serious and rare type of blood clot in combination with low blood platelets . This serious condition is called thrombosis with thrombocytopenia syndrome .
Out of an abundance of caution, the FDA and CDC recommended a pause in the use of the Janssen COVID-19 Vaccine while the FDA and CDC investigated these reports of serious adverse events. This was important, in part, to help ensure that health care providers were made aware of the potential for these adverse events and could plan for proper recognition and management due to the unique treatment required for TTS.
The safety monitoring program that is in place to monitor COVID-19 vaccines is working, as we were able to detect the reports of these serious adverse events early and take action to assess them.
J& j Covid Vaccine Is ‘safe And Effective’
Side effects in the newly approved Johnson & Johnson shot are very rare, says the head of Germany’s vaccine regulator.
in people who have received Johnson & Johnson and AstraZeneca coronavirus vaccines is extremely low, especially for the over-60 age group, a top German health official said Friday.
The president of Germany’s Paul Ehrlich Institute, Klaus Chichutek, said reports of health damage from AstraZeneca were very rare and even rarer in the case of the J& J inoculation.
He said studies from the UK had shown AstraZeneca reduced COVID-related hospitalization in people who had had the first dose by 94%.
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Viral Vector Vaccines Are Being Rigorously Studied For Safety
Viral vector vaccines for COVID-19 are being held to the same rigorous safety and effectiveness standardsexternal icon as all other types of vaccines in the United States. The only COVID-19 vaccines the U.S. Food and Drug Administration will make available for use in the United States are those that meet these standards.
While COVID-19 vaccines were developed rapidly,all steps have been taken to ensure their safety and effectiveness.
How Viral Vector Vaccines Have Been Used During Recent Disease Outbreaks
Scientists began creating viral vectors in the 1970s. Besides being used in vaccines, viral vectors have also been studied for gene therapy, to treat cancer, and for molecular biology research. For decades, hundreds of scientific studies of viral vector vaccines have been done and published around the world. Some vaccines recently used for Ebola outbreaks have used viral vector technology, and a number of studies have focused on viral vector vaccines against other infectious diseases such as Zika, flu, and HIV.
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What You Need To Know About The Fda Warning
The FDA made its decision based on preliminary reports from vaccine recipients and health care providers, made through the Vaccine Adverse Event Reporting System . This is a government reporting system that anyone can use, which collects information and helps identify unusual patterns. Of the 100 reports, 95 were serious and required hospitalization, and there was one reported death. Most of the cases were in men, and many of those men were ages 50 or older.
The agency made it clear that there is still more learn. Although the available evidence suggests an association between the Janssen vaccine and increased risk of GBS, the FDA said in a statement, it is insufficient to establish a causal relationship.
Reporting A Possible Side Effect Or Serious Reaction
Contact your health care provider if you experience:
- a side effect following vaccination with a COVID-19 vaccine
- any persistent, new or worsening symptoms
Health care providers must report possible reactions following vaccination to their local public health authority. The public health authority then reports them to the Public Health Agency of Canada.
Reported allergic reactions and side effects to COVID-19 vaccines are published weekly in our Reported side effects following COVID-19 vaccination report.
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Should You Still Choose The J& j Vaccine
The CDC says the benefits of getting the vaccine still outweigh the threat of being infected with the coronavirus.
As more people are vaccinated, fewer will become infected, and that could slow the spread of the virus, resulting in better protection for everyone. While no vaccine guarantees 100% protectionand there is more to learn about vaccine effectiveness against Omicronso far, all three COVID-19 vaccines have been very effective at preventing serious illness and death.
If you got J& J as your initial vaccine and are 18 or older, you are eligible for a booster shot two months later, regardless of which one you choose . Those ages 16 and 17 are eligible to get the Pfizer-BioNTech booster.
Note: Information provided in Yale Medicine articles is for general informational purposes only. No content in the articles should ever be used as a substitute for medical advice from your doctor or other qualified clinician. Always seek the individual advice of your health care provider with any questions you have regarding a medical condition.
Who Else Can Take The Vaccine
The vaccine is safe and effective in people with known medical conditions associated with increased risk of severe disease, such as hypertension, chronic lung disease, significant cardiac disease, obesity, and diabetes.
The WHOs Interim recommendations for an extended primary series with an additional vaccine dose for COVID-19 vaccination in immunocompromised persons can be viewed here.
WHO recommends a second dose of the Janssen Ad26.COV2.S vaccine for immunocompromised persons aged 18 years and older, given 13 months after the first dose in order to increase protection as quickly as possible. The most appropriate timing for the second dose may vary depending on the epidemiological setting and the extent and timing of immune suppressive therapy, and should be discussed with the treating physician. There are no data available to determine the need and timing of a third dose. As data become available, these recommendations will be updated.
The J& J vaccine can be offered to people who have had COVID-19 in the past. But individuals may wish to defer their own COVID-19 vaccination for up to six months from the time of SARS-CoV-2 infection, to allow others who may need the vaccine moreurgently to go first.
This vaccine can be offered to a breastfeeding woman who is part of a group recommended for the vaccination discontinuing breastfeeding after vaccination is not currently recommended.
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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.
Q: What Revisions To The Fact Sheets Did The Fda Announce On December 14 2021 Pertaining To The Occurrence Of Blood Clots In Combination With Low Blood Platelets After Administration Of The Janssen Covid
A: Monitoring the safety of the Janssen COVID-19 Vaccine continues and reports to the Vaccine Adverse Events Reporting System , a passive surveillance system, provide evidence for an increased risk of blood clots in combination with low blood platelets ) with onset of symptoms approximately one to two weeks after administration of the Janssen COVID-19 Vaccine.
The Fact Sheet for Healthcare Providers Administering Vaccine has been revised to include a Contraindication to the administration of the Janssen COVID-19 Vaccine to individuals with a history of thrombosis with thrombocytopenia following the Janssen COVID-19 Vaccine or any other adenovirus-vectored COVID-19 vaccine, such as AstraZenecas COVID-19 vaccine . The Warning section has been updated to include the most current information about the risk of TTS following administration of the Janssen COVID-19 Vaccine. Specifically, it informs that cases of TTS following administration of the Janssen COVID-19 Vaccine have been reported in males and females, in a wide age range of individuals 18 years of age and older, with the highest reporting rate in females ages 30- 49 years , and about 15% of cases have been fatal. The Fact Sheet has been revised to also convey that currently available evidence supports a causal relationship between TTS and the Janssen COVID19 Vaccine.
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What Has The J& j Booster Data Shown
For an FDA panel meeting in October to discuss authorization of its booster, J& J provided post-booster data from a large global study. The company reported that, in addition to providing 94% protection against moderate-to-severe COVID-19 in the U.S. , a booster shot given two months after the initial dose increased antibody levels by four to six times, compared to one dose alone.
Another report, a real-world study from the CDC conducted from March through August, showed the J& J single shot to be only 71% effective against hospitalization from COVID-19 in U.S. adults without immunocompromising conditions, compared to 93% for Moderna and 88% for Pfizer. But with the booster dose, the J& J vaccine could be equivalent to the mRNA vaccines, Leslie Sude, MD, a Yale Medicine pediatrician who has helped provide vaccinations, said at the time. Some vaccine experts feel that the J& J vaccine should have always been a two-dose series, but have only recently reached the phase of vaccine efficacy monitoring to confirm that idea.
As far as Omicron, the data is still coming in. Most recently, in late December, a study showed that the Johnson & Johnson shot, China’s Sinopharm vaccine, and Russia’s Sputnik V showed no neutralizing activity against Omicron. The study has not yet been peer-reviewed.
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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Q: What Data Did The Fda Evaluate To Support Emergency Use Authorization Of Janssen Covid
A: Janssen COVID-19 Vaccine is authorized to prevent coronavirus disease 2019 caused by severe acute respiratory syndrome coronavirus 2 in individuals 18 years of age and older. Primary vaccination with the Janssen COVID-19 Vaccine consists of a single dose.
For the February 2021 emergency use authorization, the FDA evaluated and analyzed the safety and effectiveness data from clinical trials conducted in over 40,000 study participants and manufacturing information submitted by Janssen Biotech, Inc. The FDA determined the totality of available data provides clear evidence that Janssen COVID-19 Vaccine may be effective in preventing COVID-19. Based on the scientific evidence available, the FDA concluded the known and potential benefits of Janssen COVID-19 Vaccine outweigh the known and potential risks for people 18 years of age and older.
How Dangerous Is Covid To The Young And Healthy
The call for social cohesion was echoed by the vice president of the Robert Koch Insitute, Germany’s public health agency.
“These weeks are very hard for all of us it is all the more important that we all stand together as a society,” said Lars Schaade.
Schaade noted that new infections were growing above all in the 30-59 age group, most of who were not yet vaccinated. He warned that the coronavirus, though mostly less deadly, was “not harmless” to younger and healthy people, with recent studies showing that 10% of people who were infected showed symptoms of “long COVID.”
Many people who have suffered even mild COVID-19 infections have been suffering from symptoms such as extreme fatigue, “brain fog” and breathing difficulties for months afterward.
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What You Need To Know About Guillain
GBS is a disease in which a persons own immune system mistakenly attacks part of the peripheral nerve system, which includes the nerve network outside of the spinal cord and brain. GBS affects an estimated 3,000 to 6,000 people a year in the U.S.
The disease can range from mild to severe, with symptoms from brief weakness to paralysis, and some people die of it. But most recover, even including the most severe cases. According to the CDC, in about two-thirds of cases, people report having had diarrhea or a respiratory illness several weeks before developing symptoms of GBS. Campylobacter jejuni infection, which causes diarrhea, is one of the most common risk factors, but people also have been diagnosed with GBS after other infections, including influenza, Epstein Barr, Zika virus, and COVID-19.
This is also not the first time people have developed GBS after getting a vaccine, according to data from the CDC. There have been reports of people getting ill from GBS days or weeks after being vaccinated with Shingrix, the shingles vaccine, and after getting the flu shot. In 1976, there was a small increased risk of GBS after swine flu vaccination, which was formulated specifically for a potential pandemic strain of flu virus.
Why Is The J& j Vaccine Only One Dose Is It Possible That It Could Eventually Become Two Doses Or That The Mrna Vaccines Could Become One Dose
The J& J vaccine went into Phase III trials as a one-dose vaccine because earlier phase trials had shown strong immune responses after just one dose, said Gandhi. After one dose, across all populations, even in older people, the antibody response and T-cell response were excellent and increased over time.
J& J is currently conducting a trial to give people two doses, which may improve efficacy against mild and moderate disease, said Gandhi.
Gandhi also noted that the J& J vaccine continues to increase in efficacy after two weeks, the current CDC-recommended waiting period after vaccination. Immunogenicity data from the Phase I/II trials suggest the immune response may continue to improve even after 28 days. I do think its going to have even more efficacy after four weeks, said Gandhi. I call it the gift that keeps on giving.
For the mRNA vaccines, the immunogenicity data after one dose did not look as powerful, so the Phase III trials were conducted with two doses. Although some real-world data suggests that one dose may also offer good protection, Gandhi said there is not enough information to recommend getting only one dose of the mRNA vaccines.
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How Well The Vaccine Works
- The J& J/Janssen COVID-19 Vaccine was 66.3% effective in clinical trials at preventing laboratory-confirmed COVID-19 infection in people who received the vaccine and had no evidence of being previously infected. People had the most protection 2 weeks after getting vaccinated.
- In the clinical trials, the vaccine had high efficacy at preventing hospitalization and death in people who did get sick. No one who got COVID-19 at least 4 weeks after receiving the J& J/Janssen COVID-19 Vaccine had to be hospitalized.
- CDC will continue to provide updates as we learn more about how well the J& J/Janssen COVID-19 Vaccine works in real-world conditions.
Q: How Can We Be So Sure About The Effectiveness Of The Janssen Covid
A: In a randomized, blinded clinical trial, participants are not aware of whether they received vaccine or placebo. Therefore, any mitigation efforts would have affected those who received vaccine and placebo equally. The relatively high number of COVID-19 cases occurring among placebo recipients suggests that any mitigation efforts among trial participants may not have been very effective at preventing COVID-19.
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