With the recent news about the Janssen/Johnson & Johnson vaccine, should I avoid getting that vaccine?
First, it’s important to know that all authorized vaccines, including the one by Janssen, are extremely safe – especially when compared to the risks associated with COVID-19.
However, when scheduling, you will be informed which vaccine is being provided. An alternative will be offered if requested and available.
Which vaccine should I get?
The widely accepted medical recommendation is that the best vaccine to receive is the vaccine that is first available for you.
Each vaccine currently available offers outstanding protection against COVID-19. Each has been scientifically tested with constant monitoring for safety with diverse populations.
Shouldn’t I take my chances with COVID, rather than a blood clot?
The risk of COVID-19 is far more significant than the very small risk of adverse effects from any of the vaccines.
With more than 230 million doses of COVID-19 vaccines administered in the United States since December, adverse effects were reported in an extremely small fraction of a percent of those who received the vaccine. In the case of the Janssen vaccine, regulators found 15 blood-clot cases among nearly 7 million recipients – a rate of just more than 2 per million, or roughly 0.0002 percent.
By comparison, thousands of unvaccinated Americans are hospitalized every single day with COVID-19.
I got the Janssen/Johnson & Johnson vaccine. Should I be concerned?
The number of blood-clot incidents with the J&J vaccine is extremely low and concentrated among women younger than 50. The pause in distribution was a precaution so scientists could investigate further, including how to treat these incidents.
As a precaution, for three weeks after receiving the vaccine, be on the lookout for: severe headache or blurred vision, shortness of breath, chest pain, leg swelling, persistent abdominal pain, or easy bruising or tiny blood spots under the skin beyond the injection site.
Seek medical care right away if you develop any of these symptoms.
About Authorized COVID-19 Vaccines
Why does it seem as if guidelines change so often?
Remember, this disease was essentially unknown before 2020, and the vaccines have been in wide use in the United States for even less time. Every day brings more studies on what is safe and what is not.
This emphasizes why it is important to apply as many precautions as possible and to keep reducing the risk to the community.
By combining individual precautions (wearing a mask in public, keeping our distance) with shared precautions (testing and vaccination efforts) we can be confident that we will bring the pandemic to an end.
Is one vaccine more effective than the other?
It is impossible to compare efficacy rates of the vaccines, and it is important to remember that they all offer outstanding protection. Each has been scientifically proven to be safe and effective in preventing severe cases and hospitalization.
Some reports have noted the overall, worldwide efficacy of the Janssen/Johnson & Johnson vaccine was lower than the rate reported for clinical trials of the Pfizer and Moderna vaccines. However, this is misleading: It is important to remember that vaccines were tested in different times and places. The Johnson & Johnson clinical trials took place when cases and hospitalizations were rising worldwide, along with troubling new variants.
What is the difference between the three vaccines?
While each takes a slightly different approach, they all are safe and effective.
The first two vaccines to be authorized for use, by Pfizer and Moderna, use mRNA technology to teach the body’s immune system to build defenses against the coronavirus. These vaccines require a booster shot several weeks after the initial injection. The vaccines also have special ultra-cold storage requirements.
The vaccine by Janssen (a division of Johnson and Johnson) uses a harmless adenovirus (such as the virus we refer to as the “common cold”) to deliver genetic instructions to teach the body to protect against the coronavirus. This is a single-shot vaccine with conventional storage requirements, making it easier to distribute.
Will taking the vaccine give me COVID-19?
No. None of the vaccines authorized for use can give you COVID-19. They do not contain the coronavirus that causes COVID-19.
How much will the vaccine cost?
The vaccine itself is funded with federal tax dollars. A small fee is charged to administer the shot, but this fee should be covered by public or private insurance, or by a government relief fund for the uninsured. Cost will not be a barrier to vaccination.
I heard that these vaccines use some new technology. Isn’t that dangerous?
The first two COVID-19 vaccines authorized for emergency use in the United States were developed using “messenger RNA,” or mRNA, to teach the body to fight off the coronavirus. Although this is a breakthrough for vaccine development, the technology has been around for decades and it has been clinically tested in the treatment of a wide range of infections. Doctors and researchers believe mRNA has the potential to fight other diseases, like cancer.
The third vaccine authorized, by Janssen (a division of Johnson & Johnson), uses a safe and proven approach that has been studied since the 1970s. It uses a harmless virus to deliver instructions to teach the body to protect against the coronavirus.
Won’t these mRNA vaccines change my DNA?
No, because, as the federal Centers for Disease Control notes, mRNA never enters the nucleus of the cell, which is where our DNA is kept. And in the case of the Janssen/Johnson & Johnson vaccine, this type of “viral vector vaccine” does not interact with DNA in any way.
The vaccines are recommended, with very few exceptions, for all adults. They have been found to be safe and effective regardless of age, race, gender or weight.
The Pfizer vaccine has been authorized for patients 12 and older. The vaccines by Moderna and Janssen (a division of Johnson & Johnson) were authorized for patients 18 and older. The difference in age ranges reflects only the different parameters set for the clinical trials of each vaccine. All vaccines are being reviewed in expanded clinical trials to include younger patients.
Women who are pregnant or breastfeeding should discuss their options with their healthcare provider before getting the vaccine, as these groups were not included in any of the early clinical trials. You should not get the vaccine if you had a severe allergic reaction after a previous dose, or if you are severely allergic to any ingredient of the vaccine.
What does the vaccine authorization for adolescents mean?
The U.S. Food and Drug Administration has expanded EUA for the Pfizer vaccine to include recipients ages 12-15. The CDC has also updated its vaccine recommendation. The vaccine has been authorized for ages 16 and older since December. Now, anyone age 12 and up is eligible for the Pfizer vaccine at Metro Health.
Clinical trials are currently underway for younger children. Plans to seek similar authorization for ages 2-11 is expected by September.
Where will the vaccine be administered?
Metro Health – University of Michigan Health is offering the COVID-19 vaccine at several locations around West Michigan.
The COVID-19 vaccine is delivered with an injection in the arm. Similar to a flu shot, the process takes just a few minutes. Depending on which vaccine you receive, you may need a booster shot several weeks later. You will receive information about scheduling the second dose, if necessary, when you schedule your vaccination.
Will I know which vaccine I am receiving?
Yes, every patient will be informed which vaccine they are receiving.
Are some doses ending up in the trash because of the short shelf life?
No. Metro Health – University of Michigan Health has taken steps to ensure no vaccine goes to waste, by maximizing the efficient use of every dose.
Because all vaccinations at Metro Health are by appointment, our team prepares only the appropriate number of doses to keep pace with the schedule. Until then, the vials stay in storage.
Do vaccine vials contain extra doses? What do you do with those?
We are following guidance from the Centers for Disease Control and the Food and Drug Administration to maximize the doses from each vial. Although initial reports indicated the vials from Pfizer contained enough for five doses, updated guidance from the FDA notes that the vials will provide up to six doses.
Our pharmacists and vaccination experts are trained to provide the precise amount for every dose.
Safety, Side Effects & Other Concerns
What are the side effects?
The most commonly reported side effects, which typically lasted several days, are pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, and fever. These symptoms, which may be more likely and noticeable after the second dose, are typically mild and temporary. They are indications that the vaccine is working.
Serious side effects are extremely rare. They include a type of blood clot called thrombotic thrombocytopenia, and an allergic reaction called anaphylaxis. Metro Health – University of Michigan Health has precautions in place, including patient monitoring and education, to further minimize the already low risk of these complications.
Is it true that younger patients have more serious side effects?
Clinical trials found that this younger age group was slightly more likely to experience fever, aches and pains. This is possibly due to the robust immune system in younger patients.
Warnings about rare allergic reactions, including anaphylaxis, are the same as for adults. Although the risk is extremely rare, the FDA says the vaccine should not be given to anyone with a history of a severe allergic reaction to any ingredients of the vaccine.
The CDC, which is closely tracking the rate of allergic reactions to vaccines, reports that they are extremely rare.
There were 21 cases of anaphylaxis after administration of a reported 1.9 million first doses of the Pfizer vaccine, equivalent to about 11.1 cases per million. Following more than 4 million first doses of the Moderna vaccine, 10 cases of anaphylaxis were reported (2.5 cases per million). The safety of the Janssen/Johnson & Johnson vaccine will be tracked in a similar way.
Although the vaccines do not contain eggs, latex or preservatives, those who have allergies to eggs or other substances should remain after vaccination for 30 minutes for observation.
Can I get the vaccine if I’ve had COVID-19 or think I may have had COVID-19 in the past?
Yes, you can choose to receive the vaccine if you’ve had COVID-19 previously. There is not enough information currently available to say if or for how long after infection someone is protected from getting COVID-19 again; this is called natural immunity. Early evidence suggests natural immunity from COVID-19 may not last very long, but more studies are needed to better understand this.
The CDC advises that previously infected people should delay vaccination until they are fully recovered. Talk with your doctor if you have questions about receiving the vaccine.
Should I get the COVID-19 vaccine at the same time as another vaccine?
The CDC recommends a gap of at least 14 days before or after getting any other vaccine, including for flu or shingles. CDC officials note they continue to review the safety of simultaneous vaccinations and may update this recommendation.
If a COVID-19 vaccine is inadvertently given within 14 days of another vaccine, you do not need to restart the COVID-19 vaccine series. Stay on schedule for your second dose.
Can the vaccines cause infertility or miscarriage?
No cases of infertility or miscarriage have been linked to the vaccines. A disinformation campaign has been circulating online, claiming that antibodies interfere with placental proteins and prevent pregnancy. This is not plausible, because no viral infections (which trigger antibody production) have been linked to infertility. The CDC has stated that pregnant or lactating patients can receive the vaccine if they are eligible, following a discussion about the relative risks.
Do the authorized vaccines contain fetal tissue?
The Janssen (a division of Johnson & Johnson) vaccine has drawn attention because the manufacturing process used cells derived from fetal tissue. These cloned cells were used to grow the harmless adenovirus that the vaccine uses to deliver genetic instructions to teach the body to protect against the coronavirus. The vaccine itself contains none of the cells.
The other two vaccines currently authorized, by Pfizer and Moderna, were tested on fetal cell lines. However, cells were not used in development or production of those vaccines.
In all cases, these cells are clones or “immortalized” copies of decades-old fetal cells. Immortalized cell lines are established by culturing fetal cells in such a way that they continue growing and multiplying indefinitely. While immortalized cell lines began with fetal cells, they no longer contain fetal body parts, and no fetal tissue remains. No cells remain from the original fetal tissue.
Do vaccinated people still need to observe restrictions, like avoiding crowds, wearing a mask, etc.?
The federal Centers for Disease Control has eased masking guidelines for fully vaccinated people, and the state of Michigan followed suit. However, masks remain required in many settings including healthcare.
The CDC guidelines state that two weeks after your final dose, you can “resume activities without wearing a mask for physically distancing,” with a few exceptions. Those include buses, planes, prisons and homeless shelters. Hospitals and healthcare settings, including Metro Health, will continue to require everyone to wear a mask.
The CDC guidance defers to local and state requirements including those established by local businesses.
Will I need to get a COVID-19 vaccine every year?
At this time, we do not know. Studies on the long-term effectiveness of the vaccine will continue and more information will be released as it becomes available.
Why did the governor extend office restrictions if people are vaccinated?
While Michigan is making progress in its vaccination rates, we have nowhere near the 70 percent to 80 percent immunity that experts estimate we need to halt the pandemic.
It’s also important to remember that the vaccines need time to reach full strength. For the two-dose vaccines, that could be at least five weeks after the first dose.
This contributes to at least two factors facing the governor when she extended the restriction on offices. One is that Michigan currently has the highest rate of infection in the country. The other is that the emergency order restricting office use was set to expire. It’s possible the renewed restrictions will be lifted sooner than six months.
Why was Michigan hit with another surge of cases?
There are multiple theories, none confirmed, but all likely to play some role. These include:
Early success in Michigan, which had one of the lowest infection rates in the nation for months, meant fewer people developed natural immunity. This was the intent of “flattening the curve,” which acknowledged many infections were inevitable but were best delayed as long as possible. But it also made Michigan fertile ground for the latest wave of infection.
The easing of some social restrictions, coupled with general weariness with those restrictions, likely has contributed to a more casual approach to precautions like wearing a mask and keeping distance.
Michigan also has among the highest rates of infection by one of the more-contagious variants, the B.1.1.7 variant first reported in Britain.
Many public health experts say Michigan offers a warning to the rest of the country, making it more urgent to address precaution fatigue and vaccine hesitancy. The last 20 percent or 30 percent of the population that needs to be vaccinated is likely to be the hardest to convince.
Can I still be a carrier if I’m vaccinated?
The risk of you developing COVID-19 remains very low if you are fully vaccinated. However, it is still possible that you could spread the virus to others. Vaccination does not completely protect you from being infected. It primarily makes your body better at fighting off the infection. That might take some time, meaning you could be carrying the virus as your immune system goes to work.
As we continue to learn more about how the virus is transmitted, it’s important to keep in mind the transmission risk for vulnerable groups. The CDC continually updates its guidance on safe activities here.
Will scientists continue tracking the safety and effectiveness of the vaccine?
Federal oversight does not end once the vaccines are approved. Local healthcare workers, who were among the first to get the vaccine, are using an after-vaccine health checker to provide additional data to a national database. Anyone who gets the vaccine may also use the vaccine reporting system – VAERS – to report side effects.
The CDC also recently released its V-safe smartphone tool, which allows users to tell the CDC about any side effects after getting the COVID-19 vaccine.