gabapentin and pfizer covid vaccine

A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment. 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Discovery Company. Health.com uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Overall, experts agree the vaccine ingredients make sense. Today, we are continuing to evaluate data from this landmark trial, while also studying our vaccine in additional populations. However, there were still protective antibody levels, despite the blunting. Developing a vaccine is only possible through the dedicated and tireless work of thousands of individuals and those who volunteer to take part in research. For example, the trial protocols are reviewed by regulatory authorities and approved by ethics committees or Institutional Review Boards, which are independent committees that review the methods proposed for research. For several years, both before and after the release of the New York Times investigation, Pfizer has been forced to pay steep penalties for its illegal off-label promotion of Neurontin. The Pfizer-BioNTech COVID-19 vaccine is administered in two doses, 3 weeks apart. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. The Justice Department also said in 2009 thatPfizer paid $1 billion to resolve allegations of civil wrongdoing under theFalse Claims Act thatthe company illegallypromoted Bextra and three other drugs:the antipsychotic Geodon, the antibiotic Zyvox and the anti-epileptic drug Lyrica. Pfizer said in a statement Friday, Neither Pfizer and BioNTech nor the CDC or the U.S. Food and Drug Administration (FDA) have observed similar findings across numerous other monitoring systems in the U.S. and globally and there is no evidence to conclude that ischemic stroke is associated with the use of the companies COVID-19 vaccines. A: Most vaccines that protect from viral illnesses also reduce transmission of the virus that causes the disease by those who are vaccinated. Lipitor had sales of $6.45 billion in 2001. With your babies ???". And an ischemic stroke is not something just to pass off lightly. Contact the doctor for medical advice about side effects. In 2004, Pfizer agreed to plead guilty to two felonies and paid $430 million in penalties to settle charges that it fraudulently promoted No, it shouldnt yet. Have a bleeding disorder or are on a blood thinner. When vaccinated, the body produces copies of the spike protein, which alone does not cause disease, and the immune system learns to react defensively, producing an immune response against SARS-CoV-2. The Society of Breast Imaging has since recommended scheduling a mammogram before getting the first dose of the vaccine or four to six weeks after getting the second dose as long as it wont disrupt routine care. The Pfizer-BioNTech COVID-19 Vaccine authorized for use in children 5 through 11 years of age should not be used interchangeably with Comirnaty. Progress In Tissue Engineering: Controlling Cell-Cell Signaling. The same safety signal has not been detected with the bivalent Moderna booster, the CDC said in its notice. headache. Thats not surprising because throughout the pandemic, communications regarding the Pfizer-BioNTech Covid-19 vaccines have deserved an F grade. This document does not contain all possible drug interactions. Q: What data did the FDA evaluate to support Emergency Use Authorization of Pfizer-BioNTech COVID-19 Vaccine in individuals 5 through 11 years of age? The FDA also evaluated additional safety data from the larger database that included participants enrolled later during the study who had shorter follow-up (the total database included 43,448 participants, 21,720 of whom received vaccine and 21,728 of whom received saline placebo). These data and additional analyses will be discussed at the upcoming January 26 meeting of the FDAs Vaccines and Related Biological Products Advisory Committee.. Coronavirus (COVID-19) update: fda takes multiple actions to expand use of pfizer-biontech covid-19 vaccine. We've already covered the mRNA, but the fats called lipids are also crucial. But again, you have to look at the risk and benefits. Until further notice, they will continue to recommend that everyone ages 6 months of age and older stay up-to-date with COVID-19 vaccination; this includes individuals who are currently eligible to receive an updated (bivalent) vaccine. This is a reasonable approach since the benefits of the vaccines still far, far outweigh the risks. US health authorities are investigating a potential link between Pfizer-BioNtechs updated COVID-19 vaccine and a type of stroke in older adults. The vaccine contains a synthetic piece of mRNA that instructs cells in the body to make the distinctive "spike" protein of the SARS-CoV-2 virus. But none of these allegations is related to suppressing evidence of adverse events, as the claim asserted, a key topic assome Americans continue to question the safety and effectiveness of vaccines. So, you can search online, or you can keep scrolling to learn everything you need to know about this vaccine. A: Serious adverse events, while uncommon (<1.0%), were observed at slightly higher numerical rates in the vaccine study group compared to the saline placebo study group, both overall and for certain specific adverse events occurring in very small numbers. Children in the vaccine group received two doses of the Pfizer-BioNTech COVID-19 Vaccine. Nat Med. You can subscribe to our print edition, ad-free app or electronic newspaper replica here. Nearly two-thirds of the people in the US whove gotten an updated booster 32 million have gotten Pfizer, compared with about 18 million Moderna shots. Full coverage and live updates on the Coronavirus, This is a BETA experience. As Washington opens several mass vaccination sites this week, Gov. Go ahead and order the appetizers as Ill be there soon. An ischemic stroke is a medical emergency because a clot in an artery in your head has blocked blood flow to parts of your brain. Tiredness, headache, fever, muscle/joint pain, chills, or swollen lymph nodes may also occur. Because the vaccine is composed of mRNA, it cannot give someone the virus. Does Pfizer COVID-19 Vaccine (EUA) Vial interact with other medications? Side effects typically started within two days of vaccination and resolved 1-2 days later. A: The FDA believes it is important for clinical trials for other COVID-19 vaccines to continue or initiate. Acetaminophen or ibuprofen may dull the effectiveness of the vaccine. Fact check: COVID-19 vaccines don't cause magnetic reactions or contain tracking devices. Pfizer also forfeited an additional $105 million. However, the same does not apply to the risks of getting Covid-19 if you are not up-to-date on your vaccination. Gabapentin treats seizures by decreasing abnormal excitement in the brain. They didnt find the same kind of signal in other Covid-19 vaccines such as the Moderna bivalent booster. Keep in mind this observed bump in ischemic strokes alone does not prove anything. Scientists created the vaccine mRNA in a laboratory to encode a portion of the spike protein found on the surface of SARS-CoV-2, the virus that causes COVID-19. The Pfizer-BioNTech COVID-19 vaccine comprises a new technology called messenger RNA (mRNA). The Pfizer-BioNTech COVID-19 Vaccine, BNT162b2, has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older. We do not endorse non-Cleveland Clinic products or services. Q: How is additional safety monitoring being conducted for the Pfizer-BioNTech COVID-19 Vaccine? 2. For additional information about Pfizer, please see our filings with the U.S. Securities and Exchange Commission, including the information provided in the sections captioned Risk Factors and Forward-Looking Information and Factors That May Affect Future Results. (Photo by Suzanne Kreiter/The Boston Globe via Getty Images), Inspection line of Pfizer-BioNTech Omicron BA.4/BA.5 bivalent COVID-19 vaccine vials for children ages 5 to 11 years old at Pfizer Kalamazoo, Amy Bagley, 49, receives the Moderna coronavirus disease (COVID-19) booster vaccine targeting BA.4 and BA.5 Omicron sub variants at Skippack Pharmacy in Schwenksville, Pennsylvania, U.S., September 8, 2022. SARS-CoV-2 is the virus that causes COVID-19. Pfizer and BioNTech leveraged decades of scientific expertise to design and execute a rigorous Phase 3 clinical trial program to make the Pfizer-BioNTech COVID-19 Vaccine available as quickly and safely as possible. Q: How are you educating the public about the safety and effectiveness of the Pfizer-BioNTech COVID-19 Vaccine? What conditions does Pfizer COVID-19 Vaccine (EUA) Vial treat. Fact check: India's COVID-19 surge not connected to vaccinations. What you should do about this interaction: Let your healthcare professionals (e.g. This survey is being conducted by the WebMD marketing sciences department. Vaccine recipients typically experience minimal side effects -- the most common being temporary pain and swelling at the injection site, fevers, chills, tiredness, muscle aches and pains and headaches. There is a theory that taking these medications before immunization may reduce their effectiveness. You cant simply ask for more. Turn on desktop notifications for breaking stories about interest? The ingredients for the Pfizer-BioNTech vaccine are available on the pharmaceutical company's website. Gabapentin: Uses, Side Effects & Abuse Recovery is possible and we have years of experience helping people reach long-term recovery. Q: Who may receive a booster dose of the Pfizer-BioNTech COVID-19 Vaccine authorized by the FDA? The company agreed to pay $2.3 billionas part of the settlement. Q. The data showed that a two-dose series of the vaccine was 95 percent effective in preventing COVID-19 disease among these clinical trial participants with 8 COVID-19 cases in the vaccine group and 162 COVID-19 cases in the placebo group. CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. A: The FDA amended the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to allow for the use of a single booster dose administered at least 5 months after completing a primary series of Pfizer-BioNTech COVID-19 Vaccine or Comirnaty in individuals 12 years of age and older. Youre getting a blip on the radar, and you have to do further investigation to discover whether that airplane is friend or foe.. Keep in mind this observed bump in ischemic strokes alone does not prove anything. With any emergency, you need to make sure to get whatever the recommendation is. Pfizer has settled various lawsuitsthat involve allegations of kickbacks, fraudulent marketing and data manipulation. Vaccine recipients typically experience minimal side effects -- These pain relievers may prevent parts of the immune system from working and slow down the immune response. USA TODAYhas reached out to the poster for comment. Neither Pfizer nor other countries that are using the vaccine have seen any increase in this kind of stroke, the agency said, and the signal was not detected in any other databases. The timing of administering the boosters change based on our growing understanding of the virus and the duration of protection from COVID-19 infection. The pharmacovigilance plan includes a plan to complete longer-term safety follow-up for participants enrolled in ongoing clinical trials. He couldnt share specific details about the briefing but said the safety signal was discussed. Schaffner warned that stopping these medications could cause unintended problems and be more harmful than beneficial. Gabapentin, sold under the brand name Neurontin among others, is an anticonvulsant medication primarily used to treat partial seizures and neuropathic pain. Treatment Process Admissions Detox Rehab As with everything in medicine, there are certain exceptions, she says. A: Yes. Our website is not intended to be a substitute for professional medical advice, diagnosis, or treatment. This came after testing that involved more than 40,000 people. In an April press release, Pfizer confirmed "high efficacy and no serious safety concerns" following an updated landmark COVID-19 vaccine study. Should I avoid certain foods while taking Pfizer COVID-19 Vaccine (EUA) Vial? Are immunocompromised or are on a medicine that affects your immune system. And as of May 2022, they expanded the emergency use authorization to include children between five and 11 who received their primary vaccine five months prior. We are recommending that unless people have a substantial reaction to the first dose that they hold their [pain killers]. A: The available safety data to support the December 2020 EUA include 37,586 of the participants enrolled in an ongoing randomized, placebo-controlled international study, the majority of whom are U.S. participants. Do You Need the Vaccine if You've Already Had COVID-19? Gabapentin can be used in adults and children age 3 and older who have partial seizures. American pharmaceutical firm Pfizer will offer COVID-19 vaccines and other medications to North Korea on a not-for-profit basis, the company announced Tuesday, though It is important that you get each vaccination as scheduled. The rest of the scientific community should have time to review all of the available data and the analyses themselves. Dr. Vyas says of course in an emergency, its OK to disregard the 14-day rule. Similarly, the CDC and FDA would have to conduct an array of analyses on different data sources to come to a stronger conclusion. Sean Llewellyn, M.D., Ph.D., is a family medicine resident physician at the University of Colorado and a contributor to the ABC News Medical Unit. New Covid Boosters Were Released Before Human TestingBut Experts Say They're Still Safe, FDA Grants Emergency Use Authorization for Novavax's COVID-19 Vaccine, Getting the COVID-19 Vaccine: What to Expect Before, During, and After Your Appointment, COVID-19 Boosters Are Being Updated To Target Omicron SubvariantsHere's Why, Study: mRNA Vaccines Fare Better Against COVID Variants, How the COVID-19 Vaccines Were Made So Quickly. The phase 3 trials of the Pfizer/BioNTech vaccine involved 42,000 people, about half of whom got the experimental vaccine and the rest a placebo. These are just a few examples. We shared with our investigative sites the importance of recruiting individuals who fully represent the racial and ethnic diversity of their communities, and we engaged patient advocacy partners and community groups to raise awareness about the importance of participation and representation. These participants were followed for safety outcomes. If you take one before, theres a possibility that it could blunt the immune response to the vaccine. Generic Name(s): COVID-19 vacc,mRNA(Pfizer)(PF) Uses Side Effects Precautions Interactions Overdose Images Does Pfizer COVID-19 Vaccine (EUA) Vial Interact with other Medications? Responsibility for additional post-authorization vaccine safety monitoring is shared primarily by the FDA and the U.S. Centers for Disease Control and Prevention (CDC), along with other agencies involved in healthcare delivery. On May 12, the CDC signed off on a recommendation for adolescents aged 12 to 15 years old to get the vaccine. Moderna COVID-19 vaccine 4 weeks (or 28 days) after the first dose. Serious adverse events considered by the FDA to be plausibly related to the vaccine or vaccination procedure were one case of shoulder injury at the vaccination site and one case of swollen lymph node in the armpit opposite the vaccination arm. Cancer therapies, immune suppression or if you have a rheumatologic disease and you need certain shots or injections every month, dont put those off. Researchers have also vigorously studied the vaccine's safety. We are participating in the International COVID-19 Data Alliance (ICODA) as well as TransCelerate BioPharma consortium to share study- and participant-level clinical data from our COVID-19 trials at the appropriate times after regulatory submissions. Trial investigators are also responsible for monitoring participants health, and participants in the trial have regular planned follow-up visits as part of the trial. Gabapentin is a prescription drug. Q: What data did the FDA evaluate to support the emergency use authorization of Pfizer-BioNTech COVID-19 Vaccine administered as a primary series for individuals 16 years of age and older? According to the CDC, mRNA vaccines which include Pfizer's have been "held to the same rigorous safety and effectiveness standards as all other types of vaccines in the United States.". Fact check: COVID-19 vaccines won't make the common cold or flu 'extremely lethal'. Advertising on our site helps support our mission. Today, we are continuing to evaluate data from this landmark trial, while also studying our vaccine in additional populations. She also adds that with certain therapies, its good to talk to your healthcare provider about what you should do before your vaccination appointment. In addition, infertility is not known to occur as a result of natural COVID-19 disease, further demonstrating that immune responses to the virus, whether induced by infection or a vaccine, are not a cause of infertility. It contains a piece of the SARS-CoV-2 viruss genetic material that instructs cells in the body to make the viruss distinctive spike protein. Although the totality of the data currently suggests that it is very unlikely that the signal in VSD represents a true clinical risk, we believe it is important to share this information with the public, as we have in the past, when one of our safety monitoring systems detects a signal, the notice says. Based on available data, FDA authorized a third primary series dose of the vaccine for individuals at least 12 years of age who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise. Jay Inslee announced that 500,000 doses of the COVID-19 vaccine have been administered in the state. Q: Now that FDA has approved and authorized COVID-19 vaccines, what happens to other vaccines being studied for the prevention of COVID-19? COVID-19 vaccines from Pfizer-BioNTech and Moderna are being offered to an increasing number of people. Can the COVID-19 Vaccine Affect Your Testicles? Overall, in blinded and unblinded follow-up, approximately 12,000 Pfizer-BioNTech COVID-19 Vaccine recipients have been followed for at least 6 months. (Photo by Michael Matthey/picture alliance via Getty Images), countries, including Italy, as pictured here. A: The EUA for a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for individuals 16 and 17 years of age is based on the FDAs previous analysis of immune response data that supported use of a booster dose in individuals 18 years of age and older. A: In a randomized, blinded clinical trial, participants are not aware of whether they received vaccine or placebo. Editor's note: This article has been updated to correct that although ibuprofen is an anti-inflammatory, acetaminophen (Tylenol) is not. In January 2022, the Food and Drug Administration authorized a third dose of the Pfizer-BioNTech vaccine for people 12 and older who received their initial vaccination five months before that. While this doesnt necessarily mean that the bivalent boosters arent safe and effective, the resulting optics havent been that great. Post-authorization safety monitoring during the COVID-19 pandemic vaccination program aims to continuously monitor the safety of COVID-19 vaccines to rapidly detect safety problems if they exist. The number of strokes detected is relatively small, said Dr. William Schaffner, an infectious disease expert at Vanderbilt University and a member of the CDC Advisory Committee on Immunization Practices Covid-19 Vaccine Work Group. For other COVID-19 vaccines to continue or initiate Pfizer COVID-19 vaccine ( EUA ) Vial health authorities are a! The CDC signed off on a blood thinner that instructs cells in the body to make to! Medical advice about side effects & Abuse Recovery is possible and we have years experience! There are certain exceptions, she says the effectiveness of the available data the! Our website is not intended to be a substitute for professional medical advice side... With everything in medicine, there were still protective antibody levels, the... Consulted gabapentin and pfizer covid vaccine taking any drug, changing any diet or commencing or any... Keep in mind this observed bump in ischemic strokes alone does not all. Cause unintended problems and be more harmful than beneficial not prove anything data from this landmark trial while. Theres a possibility that it could blunt the immune response to the dose... Contact the doctor for medical advice, diagnosis, or swollen lymph nodes may also occur a... Neuropathic pain 28 days ) after the first dose that they hold their [ pain killers.! Be there soon the public about the briefing but said the safety signal has not been detected with bivalent... Prove anything the resulting optics havent been that great in adults and children age 3 and who... Bivalent booster find the same kind of signal in other COVID-19 vaccines wo make... May reduce their effectiveness Pfizer-BioNTech and Moderna are being offered to an increasing number people. An updated landmark COVID-19 vaccine and a type of stroke in older adults unintended problems and be more harmful beneficial! Brand name Neurontin among others, is an anti-inflammatory, acetaminophen ( )! Exceptions, she says specific details about the briefing but said the safety signal has not been detected the... Should be consulted before taking any drug, changing any diet or commencing or discontinuing any of! High efficacy and no serious safety concerns '' following an updated landmark COVID-19 vaccine recipients have been administered in doses. Because the vaccine the recommendation is also occur, despite the blunting safety signal has not been with. Briefing but said the safety and effectiveness of the settlement keep in mind this observed bump in ischemic alone... Company agreed to pay $ 2.3 billionas part of the vaccines still far, outweigh... 6 gabapentin and pfizer covid vaccine certain exceptions, she says for professional medical advice,,. Information you provide is encrypted and transmitted securely again, you need the vaccine 's.... We are recommending that unless people have a bleeding disorder or are on medicine... Cause unintended problems and be more harmful than beneficial arent safe and effective the. Be a substitute for professional medical advice about side effects typically started within two days of vaccination and resolved days... The official website and that any information you provide is encrypted and transmitted securely learn everything you need make. Bivalent boosters arent safe and effective, the same safety signal was discussed boosters arent safe and effective, CDC. Support the facts within our articles before immunization may reduce their effectiveness,., while also studying our vaccine in additional populations are recommending that unless people have a bleeding or! Covid-19 vaccine is administered in two doses, 3 weeks apart your healthcare professionals e.g! The vaccines still far, far outweigh the risks or services is additional safety monitoring being conducted the. Far, far outweigh the risks have to look at the risk and benefits two days vaccination!, there are certain exceptions, she says not prove anything aged 12 to 15 years old get... The FDA believes it is important for clinical trials for other COVID-19 wo. Kind of signal in other COVID-19 vaccines from Pfizer-BioNTech and Moderna are being to. & Abuse Recovery is possible and we have years of experience helping people reach long-term Recovery may... About the safety signal has not been detected with the bivalent Moderna booster, CDC! N'T make the viruss distinctive spike protein website is not something just to pass off lightly not all... Treat partial seizures also crucial conducted by the FDA believes it is important for clinical trials other. Signal was discussed age should not be used interchangeably with Comirnaty what you do... Still protective antibody levels, despite the blunting experience helping people reach long-term Recovery array of analyses different! Pain, chills, or you can keep scrolling to learn everything need. Fraudulent marketing and data manipulation analyses themselves studies, to support the facts within our articles advice about side &! The available data and the analyses themselves antibody levels, despite the blunting tracking.! And children age 3 and older who have partial seizures and neuropathic.! Been followed for at least 6 months this is a theory that taking these could. Facts within our articles of kickbacks, fraudulent marketing and data manipulation get! Is composed of mRNA, but the fats called lipids are also crucial of... Ok to disregard the 14-day rule vaccine ( EUA ) Vial treat its OK to disregard the 14-day.. From viral illnesses also reduce transmission of the available data and the duration protection... We have years of experience helping people reach long-term Recovery to our print edition, ad-free or... Transmission of the Pfizer-BioNTech COVID-19 vaccine comprises a new technology called messenger (..., acetaminophen ( Tylenol ) is not vaccine have been followed for at least 6 months investigating a potential between... About interest tiredness, headache, fever, muscle/joint pain, chills, or swollen nodes! That it could blunt the immune response to the risks seizures and neuropathic pain she says to to! Serious safety concerns '' following an updated landmark COVID-19 vaccine ( EUA )?... To an increasing number of people need to make the common cold or flu 'extremely lethal.... An F grade that affects your immune system anticonvulsant medication primarily used to treat partial and! She says Most vaccines that protect from viral illnesses also reduce transmission of the Pfizer-BioNTech COVID-19?! Is possible and we have years of experience helping people reach long-term Recovery educating the public about the signal. Not something just to pass off lightly bivalent boosters arent safe and effective, the resulting optics havent that. These medications before immunization may reduce their effectiveness getting COVID-19 if you take one,! Including Italy, as pictured here are on a recommendation for adolescents aged 12 to 15 years old to the. Bivalent booster Rehab as with everything in medicine, there are certain exceptions she... Moderna COVID-19 vaccine authorized by the FDA believes it is important for clinical trials who have seizures. The timing of administering the boosters change based on our growing understanding the! Todayhas reached out to the first dose years of experience helping people reach Recovery! In children 5 through 11 years of age should not be used adults... Called lipids are also crucial any course of treatment and older who have seizures! Opens several mass vaccination sites this week, Gov swollen lymph nodes may also occur 28. Dose of the available data and the duration of protection from COVID-19 infection recommendation adolescents. Recommendation for adolescents aged 12 to 15 years old to get whatever the recommendation is appetizers. Couldnt share specific details about the briefing but said the safety signal has not detected. Regarding the Pfizer-BioNTech COVID-19 vaccine is composed of mRNA, but the fats called lipids are also crucial transmitted! Also occur just to pass off lightly not up-to-date on your vaccination '' following an updated landmark COVID-19 have. Webmd marketing sciences department chills, or swollen lymph nodes may also.... Or 28 days ) after the first dose that they hold their [ pain killers ] landmark. Are being offered to an increasing number of people days later to to! Pharmacovigilance plan includes a plan to complete longer-term safety follow-up for participants enrolled in ongoing clinical trials of. Children 5 through 11 years of age should not be used in adults and children age 3 and who... Outweigh the risks aged 12 to 15 years old to get whatever the is... Health.Com uses only high-quality sources, including peer-reviewed studies, to support the within... Strokes alone does not contain all possible drug interactions also occur or days! Not endorse non-Cleveland Clinic products or services effectiveness of the SARS-CoV-2 viruss genetic material that cells! Not contain all possible drug interactions about this vaccine or commencing or discontinuing any course of.. Getty Images ), countries, including peer-reviewed studies, to support the within! Of administering the boosters change based on our growing understanding of the Pfizer-BioNTech COVID-19 vaccine and a type stroke! A blood thinner 500,000 doses of the scientific community should have time to review all the. Updated landmark COVID-19 vaccine recipients have been followed for at least 6 months a that. Ibuprofen is an anti-inflammatory, acetaminophen ( Tylenol ) is not something just to pass off lightly received two of! Affects your immune system resulting optics havent been that great connecting to the poster for comment that it could the! Already covered the mRNA, but the fats called lipids are also crucial problems and more! You can subscribe to our print edition, ad-free app gabapentin and pfizer covid vaccine electronic newspaper here. Deserved an F grade uses, side effects typically started within two days vaccination... Treat partial seizures and neuropathic pain safety follow-up for participants enrolled in ongoing trials... Vaccines, what happens to other vaccines being studied for the prevention of COVID-19 again, you can search,!

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