Can A Booster Cause Moreor Worseside Effects
If you were among the unlucky recipients who felt really ill or had any of the rare but largely harmless reactions to your initial COVID-19 vaccination, you may be leery of the idea of an additional dose, in case it causes a similar or worse reaction.
But according to the FDA, the most commonly reported side effects by individuals who received a booster dose included pain, redness, and swelling at the injection site fatigue headache chills and muscle or joint pain. Swollen lymph nodes in the underarm were observed more frequently following the booster dose than after the second dose.
The FDA has been examining information about the risk of myocarditis and pericarditis following vaccination with mRNA vaccines, and has determined the benefits of a booster outweigh the risk of either condition.
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 was 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 was updated to include the most current information about the risk of TTS following administration of the Janssen COVID-19 Vaccine. Specifically, it informed 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 was revised to also convey that currently available evidence supports a causal relationship between TTS and the Janssen COVID19 Vaccine.
The FDA and CDC continue to investigate the level of potential excess risk of TTS following the Janssen COVID-19 Vaccine.
Q: What Data Did The Fda Evaluate To Support The Authorization For Emergency Use Of Administration Of A Single Vaccine Booster Dose
A: The authorization for emergency use of a single booster dose of the Janssen COVID-19 Vaccine is based on the FDAs evaluation of immune response data in 39 participants from a clinical trial including 24 participants who were 18 through 55 years of age and 15 participants who were 65 years of age and older. The study participants received a booster dose approximately 2 months after their first dose, and the results demonstrated a booster response.
Overall, approximately 9,000 clinical trial participants have received 2 doses of Janssen COVID-19 Vaccine administered at least 2 months apart, and approximately 2,700 participants have had at least 2 months of safety follow-up after the booster dose. Janssens analyses of data from these studies have not identified new safety concerns.
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Should We First Be Vaccinating The World
There is also a moral element to the question of booster shots, with some public health officials saying the focus should be on vaccinating more of the worlds population first before giving supplementary doses to those who already have some protection.
Dr. Shaw says he understands this sentiment. On this planet, we are all interdependent and we can see that many of these variants originated outside the U.S. That certainly speaks to the need to vaccinate the world, especially to drive down infection rates that support the emergence of new variants,” he says. “Ultimately, this is what needs to be done to end the pandemic.
Why Did The Fda Question The Strength Of J& js Booster Data
Even though the FDA advisory panel unanimously recommended authorization of Johnson & Johnsons booster in October, it also questioned a test used in the trial to support its application for authorization. Regulators questioned the accuracy of a test called pseudovirus neutralization assay , which is used to measure antibodies, suggesting that the low-test sensitivity could have affected the results of the clinical trial.
The upshot, though, is that despite the concern for low sensitivity of the psVNA, the advisory panel still recommended the second dose, said Dr. Sude at the time. They feel that everyone who received a first dose should be given the option to optimize protection based on the best data available at the time.
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Access To The Vaccine
Q. How can I get the vaccine in DC?
A. It is easy to get the vaccine now! All DC residents 5 and older are eligible to receive the COVID-19 vaccine, however for children 5-11, the only authorized vaccine is the pediatric dose of the Pfizer vaccine. To find a COVID-19 vaccine, search vaccines.gov, coronavirus.dc.gov, or text your Zip Code to 438829. If you are unable to leave your home, call 1-855-363-0333 and we’ll come to you.
Q: Why Did Fda Limit The Authorized Use Of The Janssen Covid
A: The FDA limited the use of the Janssen COVID-19 Vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine for the following reasons:
The Fact Sheet for Healthcare Providers Administering Vaccine was revised to reflect the authorized use of the Janssen COVID-19 Vaccine and includes a warning statement at the beginning of the fact sheet for prominence, summarizing information on the risk for TTS. Additionally, information on the revision to the authorized use of the vaccine and updated information on this risk of blood clots with low levels of blood platelets has been added to the Fact Sheet for Recipients and Caregivers.
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How Effective Is It
Johnson & Johnson announced that its single-dose vaccine was 66% percent effective at preventing moderate to severe disease from COVID-19 and 85% effective at preventing severe disease. This effectiveness in the Phase 3 trial was reached 28 days after vaccination.
The trial had a temporary delay in October when it paused for an unexplained illness, although no specific details were provided about what happened due to patient privacy. Regulators determined that the event was not related to the vaccine and the trial was safe to resume.
The efficacy against moderate to severe COVID-19 infection varied by region in the trial. It was 72% in the United States, 68% in Latin America, and 64% in South Africa.
The vaccine was also found to be fully protective against hospitalization and death, and the protection against severe disease included multiple variants of COVID-19, including the B.1.351 variant found in South Africa.
Q: What Information Was Available About Allergic Reactions At The Time Of The February 2021 Authorization
A: In the study that evaluated safety in 43,783 participants , hives were reported in five vaccine recipients and 1 placebo recipient in the 7 days following vaccination. In this study, there has been one report of severe hypersensitivity reaction, not classified as anaphylaxis, beginning two days following vaccination with Janssen COVID-19 Vaccine. The event was serious and likely related to vaccination.
In another ongoing clinical study in South Africa, one case of anaphylaxis has been reported following administration of the vaccine.
The Fact Sheet for Healthcare Providers Administering Vaccine and the Prescribing Information includes the following information, and the same general information is also included in the COVID-19 Vaccine Fact Sheets for Healthcare Providers Administering Vaccine and the Prescribing Information for the other authorized COVID-19 vaccines:
CONTRAINDICATION
Do not administer the Janssen COVID-19 Vaccine to individuals with a known history of a severe allergic reaction to a previous dose of the Janssen COVID-19 Vaccine or any component of the Janssen COVID-19 Vaccine .
WARNINGS
Appropriate medical treatment to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the Janssen COVID-19 Vaccine.
This information is also consistent with the Prescribing Information for all vaccines intended to prevent infectious diseases.
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How Do We Know If We Need A Booster
It is normal for virus-fighting antibodiessuch as those that are stimulated by a COVID-19 vaccineto wane over time. Monitoring antibody levels in the blood is one way to measure vaccine efficacy and research has found that protection remains high for six months after the second shot of a Pfizer or Moderna vaccine. However, some studies have shown a decline in antibody levels among vaccinated individuals beyond that point.
You can certainly look at antibody levels, and that does offer some indication of how much protection lasts. But even if they have waned, that doesnt necessarily mean the bodys capacity to respond to exposure is gone, Dr. Shaw says. One of the most amazing parts of the immune system is immunologic memory of past infections or vaccines. If you are re-exposed to something , the memory response is even more vigorous than the original. This memory response includes antibody responses, but also includes an additional arm of the immune system controlled by a different group of white blood cells called T cells or T lymphocytes.
T cell immune responses are especially important for viral infections like those with SARS-CoV-2, but are more difficult to study than antibody responses outside of a research laboratory setting, adds Dr. Shaw. However, T cell responses may prove to be just as important as antibody responses in protecting against infection or against serious disease requiring hospitalization, he says.
Q: How Is Additional Safety Monitoring Being Conducted For Janssen Covid
A: Janssen Biotech, Inc. has a pharmacovigilance plan that was assessed by the FDA to monitor the safety of Janssen COVID-19 Vaccine. The pharmacovigilance plan includes a plan to complete longer-term safety follow-up for participants enrolled in ongoing clinical trials. The pharmacovigilance plan also includes other activities aimed at monitoring the safety of the vaccine and ensuring that any safety concerns are identified and evaluated in a timely manner.
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What Is A Booster
The simplest answer is that its just another dose of a vaccine you received, Dr. Shaw explains. The concept is to prolong protective immunity, particularly if there is evidence that protection is waning after a period of time.
Most children receive routine vaccinations, including boosters, for illnesses such as chickenpox, tetanus, diphtheria, mumps, measles, and rubellato name a few. These vaccine series, as we call them, are recommended because you need the extra doses to get longer lasting protective immunity, Dr. Shaw says.
There is also a technical distinction between the terms third dose and booster.
Doctors use the term third dose when referring to people with compromised immune systems who may not have gotten the level of protection they need from the first two doses. The third dose provides that level of immunity.
A booster shot is recommended due to concern that the effectiveness of the vaccine decreases over time and may not protect against a new strain. A booster may be given to older people or those with chronic medical conditions or other risk factors.
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 60 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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How Does Johnson & Johnsons Vaccine Affect Covid
“It’s just too early to tell,” says Prabhjot Singh, M.D., Ph.D., chief medical and scientific advisor of CV19 CheckUp, an online tool that helps evaluate your COVID-19 risks. That goes for all of the COVID-19 vaccines we’ve seen thus far BTW, not just Johnson & Johnson, notes Dr. Singh. “Early studies suggest that risk of transmission should decrease after being vaccinated, but a definitive answer requires a formal study,” he explains.
Since the vaccines’ effects on COVID transmission are still unknown, it’s that much more important to continue wearing masks and maintaining your distance from people outside your home, says Dr. Olulade.
Bottom line: All of these vaccines seem to offer significant protection against COVID-19, which is great. Still, “a vaccine is not a license to let down your guard,” explains Dr. Olulade. “We have to unselfishly think about the health and wellbeing of others who have not yet been vaccinated and may not yet have protection from COVID.”
The information in this story is accurate as of press time. As updates about coronavirus COVID-19 continue to evolve, it’s possible that some information and recommendations in this story have changed since initial publication. We encourage you to check in regularly with resources such as the CDC, the WHO, and your local public health department for the most up-to-date data and recommendations.
‘hope Has Arrived’: Ghana Becomes First Country To Receive Covid
From CNN’s Eric Cheung and Stephanie Busari
Ghana has become the first country to receive Covid-19 vaccines through the World Health Organization’s COVAX program on Wednesday, a joint statement issued by UNICEF Ghana and WHO Ghana said.
The shipment, consisting of 600,000 doses of the AstraZeneca vaccines, arrived at 7 a.m. local time Wednesday on an Emirates flight at Kotoka International Airport, in Ghana’s capital Accra.
The minister for health-designate, Kwaku Agyeman-Manu, led a government delegation to receive the consignment. The purpose of the COVAX scheme is to buy coronavirus vaccines in bulk and send them to poorer nations that can’t compete with wealthy countries in securing contracts with the major drug companies.
As the plane carrying the vaccines landed, state-run Ghana Broadcasting Corporation journalist Abdul Hayi-Moomen declared: “The flight carrying the vaccines that we so much look forward to receiving, I believe hope has arrived.”
The vaccines were produced by the Serum Institute of India, in the Indian city of Pune, and are part of the first wave of Covid-19 vaccines headed to low and middle-income countries, the joint statement added.
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Why Was The Johnson & Johnson Vaccine Halted In The Us
The CDC and FDA asked states to temporarily halt the J& J Covid-19 vaccine after six women in the US developed a rare blood-clotting disorder.
The halt of the jab came as the United States had administered more than 6.8million doses of the J& J vaccine.
However, there has been no link to the women’s disorder and the vaccine.
“Right now, these adverse events appear to be extremely rare,” the FDA and CDC said in a joint statement at the time.
“COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously.”
All six cases occurred in women ages 18 to 48, with symptoms developing six to 13 days after they received the shot.
Doctors typically treat that type of blood clot with heparin, but health regulators noted that could be dangerous in this case and recommended a different treatment.
“Until that process is complete, we are recommending this pause,” the FDA and CDC added.
“This is important to ensure that the health care provider community is aware of the potential for these adverse events and can plan due to the unique treatment required with this type of blood clot.”
Warning: Thrombosis With Thrombocytopenia Syndrome
The Janssen COVID-19 Vaccine can cause thrombosis with thrombocytopenia syndrome which may be life-threatening.
TTS may involve thrombosis at unusual locations for a thrombus or in an extremity vein or pulmonary artery.
Among reported cases of TTS following administration of the Janssen COVID-19 Vaccine, symptoms began approximately one to two weeks after vaccination.
Instruct Janssen COVID-19 Vaccine recipients to seek immediate medical attention for shortness of breath, chest pain, leg swelling, persistent abdominal pain, neurological symptoms , or petechiae beyond the site of vaccination.
The clinical course of TTS following administration of the Janssen COVID-19 Vaccine shares features with autoimmune heparin-induced thrombocytopenia. In individuals with suspected TTS, the use of heparin may be harmful and alternative treatments may be needed.
Do not administer 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.
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