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.
These Vaccines Are Safe Right
If it has emergency use authorization from the FDA, it has been held to a very high safety standard. These vaccine trials have had just massive amounts of patients. There have been at least 30,000 patients in each one of these trials, and Johnson & Johnsons had 43,000 people. There were no harm signals in the Johnson & Johnson trials.
We have a few reports of possible severe adverse effects from the Moderna and Pfizer vaccines. Reports of severe adverse effects are being monitored and investigated closely. We still have to collect long-term safety data. For any immediate issues, those are usually collected in the vaccine trials. We have months of data now that show the vaccines are safe.
How J& j Is Different From Mrna
The Johnson & Johnson vaccine is not an mRNA vaccine . All three vaccines deliver genetic material to your cells: mRNA vaccines deliver mRNA, and Johnson & Johnson delivers DNA. Another difference is the delivery method used either a little enclosure made of fat surrounds the genetic material, or in the case of Johnson & Johnson, an adenovirus carries it. But the end result is the same: both the mRNA vaccines and the Johnson & Johnson vaccine help your body to develop antibodies against the coronavirus spike protein.
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Isnt A Main Advantage Of The Johnson & Johnson Vaccine That Youre Less Likely To Get Severely Ill From Covid
In the study population of almost 44,000 people, some of whom received a placebo and didnt get the vaccine, the Johnson & Johnson vaccine was 85% effective in preventing hospitalizations and death. Even if the vaccine wasnt 100% effective at preventing disease, it looks like it reduces severe disease. That is really what you want from a vaccine.
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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Neue Vorschriften Fr Johnson & Johnson
Die Vorgaben für Johnson & Johnson-Geimpfte sollen geändert werden, kündigte ein Sprecher des Gesundheitsministers Dienstag an, wie die Nachrichtenagentur dpa berichtet. Personen, die bei ihrer Erstimpfung Johnson & Johnson erhalten haben, gelten künftig erst nach einer zweiten Impfung als vollständig geimpft. Dies solle möglichst mit einem mRNA-Vakzin wie dem von Biontech/Pfizer oder Moderna erfolgen.
Mit diesem Schritt soll einer Stiko-Empfehlung nachgekommen werden . Diese empfiehlt allen Menschen ab 18 Jahren, die eine erste Johnson & Johnson-Dosis erhalten haben, ihre Immunisierung mit einer zweiten Impfdosis mit einem mRNA-Impfstoff zu optimieren. Eine Drittimpfung sei zudem auch nach Johnson & Johnson-Erstimpfung sowie einer Zweitimpfung sinnvoll, auch hier idealerweise mit einem mRNA-Impfstoff, so der Sprecher. Seit dem 15. Januar gelten einmalig mit Johnson & Johnson-Geimpfte laut Paul-Ehrlich-Insitut in Deutschland nicht mehr als vollständig geimpft. Gleichzeitig sollen die digitalen Impfnachweise an die jüngsten EU-Vorgaben angepasst werden. Impfzertifikate sind in der EU künftig nur noch neun Monate nach der Grundimmunisierung gültig.
Hier ein Überblick, ab wann man in Baden-Württemberg, Bayern, Nordrhein-Westfalen, Sachsen, Berlin und Brandenburg als geboostert gilt:
Should I Be Worried About Blood Clots If I Got J& j
If you got your Johnson & Johnson shot more than four weeks ago, you are not at increased risk of side effects, CDC Director Dr. Rochelle Walensky tweeted. So, if you got your Johnson & Johnson shot months ago, there is no cause for concern. Symptoms of the blood-clotting disorder typically appear within one to two weeks after receiving the vaccine, according to a fact sheet by the FDA.
Although cases of the blood-clotting disorder that occurs after vaccination with Johnson & Johnson’s and AstraZeneca’s vaccine are rare and have occurred in men and women , the risk is higher for women ages 30 to 49, occurring in one in 100,000 women.
The vaccine-induced blood clots, TTS, also require different treatment and appear to be more fatal than other blood clots that can happen in people more at risk because they take birth control pills, for example. Cases of TTS after vaccination have been fatal in 15% of cases, the FDA says, or about one in seven people. All cases of TTS required hospitalization or ICU admission, nine people have died and some needed to be treated at a post-acute care facility after their hospitalization.
In a , Johnson & Johnson said the company “remains confident in the overall positive benefit-risk profile of its COVID-19 vaccine.”
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What Is The Johnson And Johnson Covid
The JNJ COVID-19 vaccine is very different than the Pfizer and Moderna mRNA vaccines. But it still induces an adaptive immune memory response to the S-protein of the SARS-CoV-2 virus that causes COVID-19.
The JNJ COVID-19 vaccine, known as the JNJ-78436735, utilizes a recombined adenovirus vector, human Ad26.COV2.S., which expresses the S-subunit of the SARS-CoV-2 virus to induce an immune response. Basically, the adenovirus vectorcarries the genes for the S-subunit to the cell which will reproduce the protein, then inducing the immune response.
Adenovirus-based vaccines have been investigated for several decades. In fact, JNJ received approval for an Ebola adenovirus vaccine in July 2020, so the technology did not come out of anywhere just for COVID-19. However, like the mRNA vaccines, these adenovirus vaccines, also used by AstraZeneca, can be quickly developed to deliver the most important antigen on the SARS-CoV-2 virus, which is the S-protein.
There is an advantage to adenovirus-based vaccines they are much less fragile than mRNA vaccines because they are based on DNA which is more rugged than RNA.
Once the Johnson and Johnson COVID-19 vaccine is injected into the arm, the adenoviruses enter cells and moves to the nucleus, where the cells genes are located.
At this point, it is similar to the mRNA vaccines.
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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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Mixing And Matching Is Ok
The language CDC uses in the recommendation for the kind of booster to give is neutral and vague. It doesn’t specify what kind of booster to give, and this is not an oversight, said Dr. Fryhofer. The bottom line: you can boost with any authorized COVID vaccine.
The booster doesnt have to match the primary vaccine series type. This is called heterologous boosting, she added. On the other hand, boosting with the same type of vaccine as the one you originally received is called homologous boosting. Either strategy is permitted.
But Don’t We Need J& j
Johnson & Johnson’s vaccine is easier to store than Pfizer’s and Moderna’s vaccines. It’s also the only one-dose COVID-19 vaccine authorized by the FDA, which has made it an attractive option to give out in places such as homeless shelters, prisons, airport vaccine clinics and to people living in “hard-to-reach” communities who may not be able to show up for a second dose. Also, it’s an alternative to mRNA vaccines, which has contributed to vaccine hesitancy in some people .
However, some experts on the CDC panel questioned Johnson & Johnson’s status as a one-dose treatment as a reason to recommend the vaccine, given that everyone who received it is being told to get a COVID-19 booster sooner than those who got Moderna or Pfizer because of its lower effectiveness. If people living in communities that don’t have as much access to health care continue to be given a vaccine scientists say isn’t as good, it could worsen health care inequities in the country.
“It’s not all about ease,” pediatrician and CDC committee member Dr. Pablo Sanchez said in December. “It is not a single-dose vaccine anymore.”
Even if the CDC’s new guidance for Johnson & Johnson’s vaccine levels the playing field in the US, it may contribute to problems abroad. CDC members also raised questions Thursday about how the US’ recommendation on Johnson & Johnson will impact distribution around the world.
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What Is Thrombosis With Thrombocytopenia
Thrombosis with thrombocytopenia, also known as vaccine-induced thrombatic thrombocytopenia, is the combination of a blood clot with low platelet count. The blood clots form in unusual places, such as veins that drain blood from the brain.
Studies have shown the risks of developing a blood clot from COVID-19 is still far greater than from the vaccines, and the benefits of getting vaccinated continue to outweigh the risks.
What Do We Know About J& js Protection Now
The largest real-world study to date, sponsored by Johnson & Johnson, showed a single shot of the vaccine provided protection against COVID-19 breakthrough infections, hospitalizations and intensive care unit admissions for up to six months, the company announced Thursday.
Last year, it said a single dose of its vaccine offered 70% protection against moderate to severe forms of the disease, with a second shot given about two months after the first increasing the effectiveness to 94%.
Besides stimulating the immune system to produce antibodies, vaccines also induce T cells, another layer of protection.
The major plus for the J& J vaccine is that it does induce very high levels of cytotoxic T cells. These are cells that are instructed to kill virus-infected cells, Kuritzkes said.
The T cells are persisting whether or not antibody levels are decreasing, which may explain why J& Js level of protection appeared to remain pretty stable at six months compared to the decline observed for the mRNA vaccines though they still started off with a higher level of protection, he noted.
Studies continue on how durable and stable the protection of all the vaccines is.
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What Is Johnson & Johnson Vaccine
Unlike Pfizer-BioNTech vaccine and Moderna vaccine which are mRNA based vaccines, the new Johnson & Johnson COVID-19 vaccine is based on the development and production of adenovirus vectors. This vaccine is developed by Belgian company Janssen Pharmaceuticals which is owned by Johnson & Johnson. The Janssen COVID-19 vaccine is based on viral vector technology which uses a genetically modified adenovirus to carry the gene for making spike proteins of the novel coronavirus. The virus has been altered so that it cannot harm the body. The vaccine claims to be equally effective as Pfizer and Moderna vaccines in terms of deaths and hospitalizations.
In June 2020, Johnson & Johnson began conducting clinical trials of the vaccine for efficacy and almost 43,000 participants volunteered for the phase 3 clinical trials. After months of study and trials, finally in January 2021, the company had showed their data based on which the vaccine has achieved a 66% efficacy in a single-dose regimen in fighting off symptomatic COVID-19 after 28 days. Considering the Janssen vaccine has been tested under more serious circumstances with all the new variants around including the UK variant, it proves to be highly effective compared to other vaccines. Also, the Janssen vaccine is 100% effective against hospitalizations and deaths, which is great.
How Effective Is It
The FDAs analysis found that, in the U.S., the Johnson & Johnson COVID-19 vaccine was 72% effective at preventing all COVID-19 and 86% effective at preventing severe cases of the disease. While there is still a chance a vaccinated person could get sick, this suggests they would be much less likely to need hospitalization or to die from COVID-19.
A similar trial in South Africa, where a new, more contagious variant is dominant, produced similar results. Researchers found the Johnson & Johnson vaccine to be slightly less effective at preventing all illness there 64% overall but was still 82% effective at preventing severe disease. The FDA report also indicates that the vaccine protects against other variants from Britain and Brazil too.
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If You Had The J& j Vaccine Without Any Blood Clot Problems Is It Ok To Get The Second Shot
Its unclear, both experts said. The vaccine has been linked to the risk of rare but potentially life-threatening blood clots. At least 54 people in the U.S., mostly younger women, have been hospitalized from these blood clots, and nine people have died.
For those considering a J& J booster, the risk may linger even if they experienced no problems with the initial shot.
Just because that didnt happen the first time around, Im not sure you could guarantee it wouldnt happen the second time around, Kuritzkes said.
If you were an older person or a man and wanted to get a boost of J& J and you did fine with the first the shot, its probably fine. I would still have some hesitation if I were a young woman getting boosted with the J& J.
Arent Cold Storage And Stability Some Of The Reasons The Rollout Of The Vaccine Has Been A Challenge
We have the capacity in a lot of the U.S. to get the cold storage mRNA vaccines out, but it can be a challenge in rural areas. When you start talking about a vaccine that is more stable and only involves a single shot, this is great news. The easier it is to give, the more people were going to vaccinate in the U.S. But this is also true internationally, where delivering a tricky mRNA vaccine can be a challenge in some areas due to the cold storage requirements.
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Everyone Should Still Get Vaccinated
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.
What Is This Fda Expert Review
Almost all of the information in this article will come from the Johnson and Johnson COVID-19 vaccine documents that were submitted for review by the Vaccines and Related Biological Products Advisory Committee in advance of an emergency use authorization once the FDA reviews and approves the findings. I read through most of the material to save you all time during this holiday season .
There is a myth pushed by the anti-vaccine crowd that the FDA summarily approves vaccines without even a cursory review. They think that the FDA trusts anything Big Pharma submits to them without thinking. That couldnt be further from the truth.
Every drug, including the JNJ COVID-19 vaccine, is almost always reviewed by an expert committee of scientists alongside career FDA scientists. These are thorough, scientific, and open.
For vaccines, the Vaccines and Related Biological Products Advisory Committee, also known as VRBPAC, are made up of experts in vaccines, public health, and statistics. There are around 30 individuals on the committee including one vaccine industry scientist and one consume representative. All of the voting members of VRBPAC are scientists, statisticians, physicians, and FDA experts.
According to the FDA, the committee is charged with:
These experts are not industry shills. They are some of the leading experts in all fields of vaccinology, not amateurs with a 15-minute education on vaccines. VRBPAC is a dignified committee that puts scientific evidence above all else.
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