Q: Is There A Shortage Of Personal Protective Equipment Such As Gloves Masks And N95 Respirators Or Of Ventilators
A: The FDA has been working closely with PPE and ventilator manufacturers to understand their supply capabilities during this pandemic. The agency is also aware of challenges throughout the supply chain that are presently impacting the availability of PPE products and is taking steps to mitigate shortages that health care facilities are already experiencing.
The FDA issued new guidance to give ventilator manufacturers and non-medical device manufacturers more flexibility to start making new ventilators and parts. We adjusted our screening of PPE and medical devices at U.S. ports of entry to expedite imports of legitimate products into the U.S. With CDC we took action to make more respirators, including certain N95s, available to health care personnel for use in health care settings. Read more about PPE.
The FDA encourages manufacturers and health care facilities to report any supply disruptions to the device shortages mailbox at .
The 3rd Dose Vs 4th Dose
The antibody response to the spike protein was 1.59-fold higher at 14 days after the fourth dose of the Pfizer vaccine than 28 days after the third dose.
Similarly, a fourth dose of the Moderna vaccine resulted in a 2.29-fold higher antibody response than after the third dose.
The magnitude of the T-cell response was similar after the third and fourth vaccine doses. However, there was a more pronounced T-cell response after the fourth dose in the group that received three initial doses of the Pfizer vaccine and a fourth dose of the Moderna vaccine.
The researchers did not observe an age difference in the immune response after the fourth dose.
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But since the J& J vaccines arrival on the scene it has faced a number of challenges. A production snafu in the hands of a contract producer contaminated 15 million doses, which had to be destroyed. In mid-April, the FDA and CDC paused use of the vaccine as they investigated whether it triggered a rare but dangerous side effect diffuse blood clots that formed even though affected people had low levels of clot-forming platelets. Continuing concern about that condition, called thrombosis with thrombocytopenia syndrome, or TTS, led the CDC on Dec. 16 to advise people to choose Moderna or Pfizer over the J& J vaccine.
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Q: What Is The Fda Doing To Protect People From Products Making Fraudulent Covid
A: We have established a cross-agency team dedicated to closely monitoring for fraudulent COVID-19 products. In response to internet scammers, the FDA has taken and continues to take actions to stop those selling unapproved products that fraudulently claim to prevent, treat, diagnose or cure COVID-19. The FDA and the Federal Trade Commission issue warning letters to companies and individuals that are unlawfully selling unapproved products with fraudulent COVID-19 claims. The FDA also has taken enforcement action against certain sellers that continued to illegally market products for prevention or treatment of COVID-19.
Additionally, the FDA also has reached out to major retailers to ask for their help in monitoring online marketplaces for fraudulent COVID-19 products. You can report websites selling fraudulent medical products to the FDA through our website, by phone at 1-800-332-1088, or email to . Read more in the consumer update on fraudulent products.
Organizations Get Different Types
Which vaccine a patient gets is dependent on the vaccination site. While one site may get Moderna, another might have Pfizer-BioNTech and then others might get J& Js COVID-19 vaccine.
My hospital has both the Moderna and the Pfizer, but the most important thing is whatever you get for the first dose, you have to get for the second dosetheres no mixing and matching, she said. You want to get the full series.
One big advantage of the Janssen vaccine is it only requires one dose, said Dr. Fryhofer. This means you dont have to come back for a second appointment. It also means only one set of vaccine side effects.
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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.
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“We hope to use this information to better counsel patients wondering about vaccination in the first versus the second or third trimester,” Edlow said in a hospital news release.
The researchers studied the antibody responses in 158 pregnant women who used Janssen’s adenovirus-based vaccine, Moderna’s mRNA vaccine and Pfizer’s mRNA vaccine. They also evaluated maternal and umbilical cord blood in 175 maternal-neonatal pairs.
The team found lower-functioning antibodies in women who received the adenovirus-based vaccine than in those who received the mRNA vaccines. It also found subtle advantages in antibody levels and function in women who received the Moderna vaccine over the Pfizer vaccine.
The mRNA vaccine-induced antibodies had higher levels and functions against the Alpha, Beta, Delta and Gamma variants, as well as vaccine-induced antibodies with neutralizing activity against Omicron.
Getting vaccinated in the first or third trimesters lead to more maternal immune responses relative to second-trimester vaccination. However, the transfer of antibodies to the fetus through the placenta was most efficient with first and second trimester vaccination.
The authors called for further research.
The findings were published in Nature Communications.
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Q: What Is The Difference Between The Types Of Tests Available For Sars
A: There are two different types of tests diagnostic tests and antibody tests.
Getting An Additional Dose Of The Vaccine
After getting the initial series, getting another dose of vaccine might help people with a weakened immune system to build up a stronger immune response against the virus that causes COVID-19 .
Pfizer-BioNTech and Moderna vaccines
The CDC recommends a third dose of the mRNA vaccines for people with moderately to severely weakened immune systems. This includes, for example, people who have:
- Been getting active cancer treatment
- Received a stem cell transplant or CAR T-cell therapy within the last 2 years or are taking medicine to suppress the immune system
- Been getting active treatment with high-dose corticosteroids or other drugs that may suppress the immune response
The third dose of vaccine should be given at least 4 weeks after the second dose. Whenever possible, the same mRNA vaccine should be used for the third dose, according to the CDC. If the same vaccine isnt available , then either mRNA vaccine may be given for the third dose.
People who receive this third dose are also eligible for a booster dose of vaccine, according to the CDC. This should be given at least 6 months after the third dose.
Johnson & Johnson vaccine
While the CDC does not recommend an additional dose at this time for immunocompromised people who initially received the Johnson & Johnson vaccine, they do recommend getting a booster shot at least 2 months after the initial dose. Any of the three available vaccines can be given for this booster dose.
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Q: What Is The Fda Doing To Respond To The Covid
A: The FDA, along with other federal, state, and local agencies and public health officials across the country and internationally, plays a critical role in protecting public health during the COVID-19 pandemic. FDA staff are working around the clock to support development of medical countermeasures and are providing regulatory advice, guidance, and technical assistance to advance the development and availability of vaccines, therapies, diagnostic tests and other medical devices for use diagnosing, treating, and preventing this novel virus. The FDA continues to monitor the human and animal food supply and take swift action on fraudulent COVID-19 products.
Vaccination Doesn’t Affect Fertility
The CDC recommends COVID-19 vaccination and boosters for pregnant and breastfeeding women, as well as for women who are trying to become pregnant or who might become pregnant in the future.
The CDC points to a growing body of evidence supporting the vaccines’ safety in this vulnerable population, including:
- No effect on chances of pregnancy in more than 2,000 women ages 21 to 45
- No link with preterm birth or underdevelopment at birth in a study of more than 40,000 pregnant women
- No miscarriage risk among women who received mRNA vaccines just before and up to 20 weeks into pregnancy
- No safety concerns reported on three vaccine-monitoring systems among infants or mothers vaccinated with an mRNA shot during late pregnancy
Any known or possible risks of vaccination for pregnant people are the same as the risks for people who are not pregnant. Also, vaccination does not harm fetuses.
COVID-19 can cause serious illness and hospitalization in pregnant women. It also can lead to a greater likelihood of pregnancy complications, such as preterm birth or stillbirth.
Speak with your doctor about vaccination if you are pregnant or your immune system is at risk. They can help clear up any questions or concerns.
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Q: What Is The Fdas Role In Helping To Ensure The Safety Of The Human And Animal Food Supply
A: To protect public health, the FDA monitors domestic firms and the foods that they produce. The FDA also monitors imported products and foreign firms exporting to the United States. The FDA protects consumers from unsafe foods through research and methods development inspection and sampling and regulatory and legal action.
Do Kids Even Need To Be Vaccinated For Covid
Children are less likely to experience severe illness than adults, but some have become extremely sick. The omicron wave was specifically hard on children, leading to an increase in juvenile hospitalizations. Between December 2021 and February 2022, nearly 90% of children 5 to 11 who were hospitalized were unvaccinated, according to the CDC.
Of those children, 30% had no underlying medical conditions that would have made them more susceptible to more serious complications. An found that 75% of children age 11 and younger showed evidence of previous coronavirus infection, with roughly one-third becoming newly seropositive since December 2021. But having antibodies for the virus “should not be interpreted as protection from future infection,” the agency said in a statement.
“Vaccination remains the safest strategy for preventing complications from SARS-CoV-2 infection, including hospitalization among children and adults.” Kids 5 to 11 who have COVID-19 also have a higher risk of multisystem inflammatory syndrome, or MIS-C, a rare but potentially serious complication that can involve inflammation of the heart, lungs, kidneys, brain, skin, eyes and other organs. More than 2 million cases of COVID-19 have been reported in children 4 years old or younger in the US, according to the CDC, resulting in 442 deaths.
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How To Choose Which Vaccine Is Right For You
All three current vaccines are effective against preventing severe COVID-19 illness. According to healthcare officials and medical experts, it truly doesnt matter which vaccine you get – simply that you get vaccinated. Unfortunately, there is not enough of any one vaccine for people to choose which one they want. Hopefully, someday that will be the case. Individual states submit vaccine requests to the U.S. government who then distribute the vaccine based on supply and equal distribution. The vaccine is then distributed amongst the counties and healthcare systems.
At this point, according to the U.S. Department of Health and Human Services and Dr. Anand Parekh chief medical advisor for the Bipartisan Policy Center, states do not have the ability to request specific vaccines beyond needing second doses for those that have already received their first dose of the Pfizer or Moderna vaccine.
Individuals that are 16 and 17 years old are only able to receive the Pfizer vaccine because of their age. For this reason, they are allowed to request a specific vaccine when applying for vaccination. But otherwise, there is no way to ask for a specific vaccine.
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Is It Ok For Cancer Caregivers To Get The Vaccine
Yes. In fact, getting the vaccine can help lower the risk that the person youre caring for might get COVID-19.
Some vaccines for other diseases contain changed versions of the live viruses that cause the diseases. These types of live virus vaccines typically are not recommended for cancer caregivers because they might have unwanted effects on cancer patients. However, the available COVID-19 vaccines do not contain these types of live viruses, so getting one of these vaccines does not put you at risk for passing COVID-19 on to the person youre caring for.
Its important to know that if you do get a COVID-19 vaccine and are later exposed to the virus, its not yet clear if the vaccine will prevent you from infecting someone else .
For people who are fully vaccinated , the CDC has guidance on things you can now do , as well as what types of precautions you should still be taking. The CDC also has guidance on who might be eligible for a third dose or booster dose of the vaccines. This guidance is being updated regularly, so check the CDC website for details. The CDC guidance may not apply if you have a weakened immune system , so its important to talk a health care provider about which precautions you still need to take.
People getting the vaccine might not feel well for a few days after each shot, so it might make sense to have someone else available to help with caregiving during this time.
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Which Vaccine Is The Best One
The experts agreed: The best vaccine is the one that is first available to you.
What I tell my patients and family members is to take whatever vaccine you can get, says Mark Mulligan, MD, a professor at NYU Grossman School of Medicine and director of the NYU Langone Vaccine Center, who led the clinical trials for the AstraZeneca and Pfizer vaccines at New York University . Theyre all highly effective. You cant really make any discernment from one to another.
Some have speculated that the Pfizer and Moderna vaccines with their roughly 95% efficacy rates in clinical trials are better than the Johnson & Johnson vaccine and the AstraZeneca vaccine . But comparing the different vaccines efficacy rates is sometimes like comparing apples and oranges, according to Anna Durbin, MD, a professor at Johns Hopkins University School of Medicine and Johns Hopkins Bloomberg School of Public Health in Baltimore who specializes in infectious disease and vaccines.
What I tell my patients and family members is to take whatever vaccine you can get. Theyre all highly effective. You cant really make any discernment from one to another.
Another complication is what the researchers conducting the clinical trials were measuring. The efficacy number reported in clinical trials was against any COVID-19 symptoms even mild ones.
What were trying to do is prevent severe illness, Durbin explains. All of them are close to 100% at preventing hospitalized COVID-19.
Q: What Does It Mean To Be An Fda
A: FDA approval of a drug means that the agency has determined, based on substantial evidence, that the drug is effective for its intended use, and that the benefits of the drug outweigh its risks when used according to the products approved labeling. The drug approval process takes place within a structured framework that includes collecting clinical data and submitting an application to the FDA. Learn more about the FDAs Drug Review Process.
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