There is no scientific evidence that the vaccine could cause infertility in women. In addition, infertility is not known as a result of a natural COVID-19 disease, demonstrating once again that immune responses to the virus, whether induced by infection or vaccine, are not a cause of infertility. Reports on social media have falsely claimed that the vaccine could cause infertility in women, and the FDA is concerned that this misinformation could lead women to avoid vaccination to prevent COVID-19, which is a potentially serious and life-threatening condition. SARS-CoV-2 is the virus that causes COVID-19. Symptoms of COVID-19 vary and are unpredictable; Many people have no symptoms or only mild illness, while some suffer from serious respiratory illnesses such as pneumonia and acute respiratory distress syndrome (ARDS), leading to multiple organ failure and death. Comirnaty is an mRNA vaccine. It contains a piece of the genetic material of the SARS-CoV-2 virus, which instructs the body`s cells to make the virus` distinctive protein. Once a person is vaccinated, their body produces copies of the spike protein, which does not cause disease, and triggers the immune system to learn to respond defensively, which causes an immune response against SARS-CoV-2. Contrary to fake reports on social media, this protein is not the same as any protein involved in the formation of the placenta. “[1] The authorised vaccine must have the same formulation as the EEE-authorised vaccine and the products may be used interchangeably to provide the vaccine series without raising safety or efficacy concerns.
The products are legally different with some differences that do not compromise safety or efficacy. The FDA`s Pfizer/Comirnty vaccine fact sheet warns recipients that these are two separate products: “They will be offered either COMIRNATY (COVID-19 vaccine, mRNA) or Pfizer-BioNTech`s COVID-19 vaccine to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2.” The factsheet states that “the products are legally different, with some differences that do not compromise safety or efficacy”. The FDA wants a single fact sheet on combination vaccines. A single sheet of paper simplifies things for those who administer and receive vaccines. Since branded vials and branded vials containing vaccines are chemically identical, although legally different, this information should be included. These rules include conducting a series of studies focused on people under the age of 16 in order to gain full approval in this population. These studies are already underway. Companies must also conduct post-approval trials for people over the age of 16 to monitor the safety and efficacy of the vaccine. Furthermore, Comirnaty is not excluded from any legal liability. If you wish to receive the vaccine, you can specifically request Comirnaty for this reason. First, the Pfizer-branded vaccine is still marketed under the FDA`s Emergency Use Authority (EUA), which means people have the right to opt out.
Federal law states that recipients of an unapproved emergency product (i.e., a product distributed under the EEA) “must inform the persons to whom the product is administered of the possibility of accepting or refusing to administer the product.” (21 United States Code § 360bbb) Most vaccines that protect against viral diseases also reduce transmission of the virus that causes the disease from those who are vaccinated. Although it is hoped that this will be the case, the scientific community does not yet know whether Comirnaty will reduce this transmission. Can Comirnaty and the Pfizer-BioNTech COVID-19 vaccine be used interchangeably? On the other hand, if these cameo characters are famous enough, you`ll probably get away with a more candid reference. In a joint media statement released by Pfizer and BioNTech on December 21, 2020, the companies said: “The vaccine will be marketed in the EU under the brand name COMIRNATY, which is a combination of the terms COVID-19, mRNA, community and immunity to mark the first approval of a messenger RNA (mRNA) vaccine… BioNTech is the German biotech company that partnered with Pfizer to bring this COVID-19 vaccine to market. The FDA conducted a rigorous evaluation of post-approval safety surveillance data for myocarditis and pericarditis following administration of the Pfizer-BioNTech COVID-19 vaccine and found that the data increased the risks, particularly within seven days of the second dose. The observed risk is higher in men under 40 years of age than in older women and men. The observed risk is highest in men aged 12 to 17 years. Available data from short-term follow-up suggest that most people resolved symptoms.
However, some people needed intensive medical support. There is still no information on possible long-term health consequences. The prescribing information for Comirnaty contains a warning regarding these risks. If a person has received Comirnaty, does the vaccine protect against transmission of SARS-CoV-2 from infected people despite vaccination? What is the link between Comirnaty (COVID-19 vaccine, mRNA) and Pfizer-BioNTech`s COVID-19 vaccine, which is approved for emergency use? The most frequently reported adverse reactions in clinical trial participants who received Comirnaty were pain, redness and swelling at the injection site, fatigue, headache, muscle aches, chills, joint pain and fever. On the other hand, there is no legal right of opt-out for Comirnaty. Religious exceptions and shelters are still available, but we anticipate they will be harder to obtain, and some jurisdictions may ban them altogether, as has happened in some states with vaccination requirements for school-aged children. According to media reports, the renowned vaccine is identical to the original vaccine in all respects. That`s not true. “Pfizer Comirnat” and “Pfizer BioNTech COVID-19 vaccine” are biologically and chemically the same thing.
After Bart reads Willie`s mind, the guard explains that he was given the “shin”. Bart tries to correct the word, but Willie warns him of the danger of copyright. How did the FDA make the decision to approve Comirnaty (COVID-19 vaccine mRNA)? What is different now from the approval of the Pfizer-BioNTech COVID-19 vaccine in December 2020? The EEA for the Pfizer-BioNTech COVID-19 vaccine for individuals 16 years of age and older was based on safety and efficacy data from an ongoing randomized, controlled, blinded clinical trial in approximately 18,000 people who received the vaccine and approximately 18,000 who received placebo. The vaccine was 95% effective in preventing COVID-19 disease in these clinical trial participants with eight cases of COVID-19 in the vaccinated group and 162 in the placebo group. The median safety follow-up for vaccinated and placebo participants was two months after the second dose. Overall, the vaccine was 91% effective in preventing COVID-19 disease, with 77 cases of COVID-19 in the vaccinated group and 833 cases of COVID-19 in the placebo group. Yes. Among study participants, which the FDA evaluated for approval in December 2020, relatively few confirmed cases of COVID-19 occurred overall among clinical trial participants with signs of SARS-CoV-2 infection prior to vaccination. These trials are an integral part of the post-approval process that most drugs must go through to maintain full FDA approval. This list of required trials does not mean that the vaccine is not fully approved. No. As for what is contained in the bottle, they are identical.
Pfizer and BioNTech simply officially “tagged” their vaccine or named Comirnaty. Yes. Following the issuance of the EEA, clinical trial participants were gradually unblinded over a period of several months to offer placebo participants the approved Pfizer-BioNTech COVID-19 vaccine. These participants were observed for safety outcomes. In total, approximately 12,000 people who received the Pfizer-BioNTech COVID-19 vaccine were followed for at least 6 months blinded and unblinded. Second, vaccines are protected from liability under the EEA. If you have a serious adverse event as a result of the vaccine, as is the case with more than 1.2 million people in the United States, you have no legal recourse. All you can do is contact the Countermeasures Compensation Program, which has refused to compensate 96% of claimants in the past. There is no data yet on how long the vaccine will provide will last.
After the FDA granted emergency use authorization for Pfizer BioNTech`s COVID-19 vaccine, were clinical trial participants blinded so that the vaccine could be offered to placebo recipients? The formulation of the Pfizer-BioNTech COVID-19 vaccine, which is approved for children aged 5 to 11 years, differs from the formulations approved for the elderly. The Pfizer-BioNTech COVID-19 vaccine, which is approved for use in children 5 to 11 years of age, should not be used interchangeably with Comirnaty. Pfizer and BioNTech received approval to market the vaccine in the U.S. under the name Comirnaty as part of the recent FDA approval. The FDA approval letter states: “You may label your product with the brand name Comirnaty and market it in 2.0ml glass vials in packs of 25 and 195 vials.” Pfizer-BioNTech`s COVID-19 vaccine is also approved for use as a single heterologous dose (or “blend and match”) for individuals 18 years of age and older after completion of primary immunization with another approved COVID-19 vaccine.