Logan Reed
The COVID-19 pandemic has caused unprecedented disruption to global health and economies. Vaccines have been developed and deployed at speed to help curb the spread of the virus and its variants. The FDA has approved several COVID-19 vaccines, including the Pfizer-BioNTech vaccine, which was the first to receive approval in 2021. This vaccine is now marketed as Comirnaty for individuals 16 years of age and older. The Moderna vaccine received approval in 2022, and the FDA has also approved updated mRNA vaccines for 2024-2025, including Comirnaty and Spikevax, to provide better protection against circulating variants.
| Characteristics | Values |
|---|---|
| First FDA-approved COVID-19 vaccine | Pfizer-BioNTech COVID-19 Vaccine |
| Marketed as | Comirnaty |
| Age group approved | 16 years and older |
| Age group under EUA | 12-15 years |
| EUA for second COVID-19 vaccine | Moderna COVID-19 Vaccine |
| Age group approved | 18 years and older |
| EUA for third COVID-19 vaccine | Johnson & Johnson |
| mRNA COVID-19 vaccines approved | Comirnaty and Spikevax |
| Manufacturer of Spikevax | ModernaTX, Inc. |
| mRNA COVID-19 vaccines side effects | Myocarditis and Pericarditis |
| Age group approved for updated mRNA COVID-19 vaccines | 12 years and older |
| Manufacturer of Comirnaty | BioNTech Manufacturing GmbH |
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What You'll Learn
The Pfizer-BioNTech COVID-19 vaccine
In December 2020, the United Kingdom was the first country to authorize its emergency use. The Pfizer-BioNTech vaccine was then approved in the US by the Food and Drug Administration (FDA) on 23 August 2021. The vaccine is authorized for use at some level in the majority of countries.
Comirnaty contains messenger RNA (mRNA), a type of genetic material. The mRNA is used by the body to mimic one of the proteins in the virus that causes COVID-19. The vaccine is given by intramuscular injection and is composed of nucleoside-modified mRNA (modRNA) that encodes a mutated form of the full-length spike protein of SARS-CoV-2, encapsulated in lipid nanoparticles.
Initial guidance recommended a two-dose regimen, given 21 days apart. This interval was later extended to up to 42 days in the US and up to four months in Canada. In December 2021, Pfizer and BioNTech reported that a third dose of the vaccine would provide a similar level of neutralizing antibodies against the Omicron variant as seen after two doses against other variants. The U.S. Centers for Disease Control and Prevention (CDC) recommends that pregnant women get vaccinated with the COVID-19 vaccine.
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Comirnaty
The FDA conducted a rigorous evaluation process for Comirnaty, including the analysis of hundreds of thousands of pages of scientific data and information. The FDA also conducted its own analysis of the vaccine's safety and effectiveness and performed detailed assessments of the manufacturing processes, including inspections of the facilities. This approval process ensures that Comirnaty meets the FDA's high standards for safety, effectiveness, and manufacturing quality.
It is important to note that continuous monitoring and assessment of the safety of all vaccines, including Comirnaty, is a priority for the FDA. As part of the approval process, the FDA has required updated warning labels for Comirnaty regarding the risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) following vaccination. These risks have been included in the vaccine's labelling since 2021, and each manufacturer is required to conduct studies to assess potential long-term heart effects.
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Spikevax
The FDA has approved updates to the prescribing information for Spikevax to include safety information about the risks of myocarditis and pericarditis following administration. Myocarditis is the inflammation of the heart muscle, and pericarditis is the inflammation of the lining outside the heart. The FDA has been monitoring the safety of all vaccines, including COVID-19 vaccines, and has required each manufacturer to conduct a study to assess any long-term heart effects in people who have had myocarditis after receiving an mRNA COVID-19 vaccine.
The FDA has also approved the 2023-2024 formula for Spikevax, changing it to a single dose for individuals 18 years of age and older, and approving a single dose for individuals 12 through 17 years of age. The vaccine was previously approved as a two-dose series for individuals 18 years of age and older.
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Moderna COVID-19 vaccine
The Pfizer-BioNTech COVID-19 vaccine is the first to be approved by the FDA. However, the FDA has issued an Emergency Use Authorization (EUA) for the Moderna COVID-19 vaccine, which is distinct from full FDA approval. The Moderna COVID-19 vaccine has been authorised for use in individuals 6 months through 11 years of age. The 2024-2025 formula includes a monovalent component that corresponds to the Omicron variant KP.2 strain of SARS-CoV-2.
The EUA is a declaration that allows the emergency use of unapproved medical products or unapproved uses of approved medical products in response to public health emergencies. This means that the Moderna vaccine has not been fully approved or licensed by the FDA, but it has been authorised for use during the COVID-19 public health emergency. The EUA is in effect unless the declaration is terminated or revoked.
The Moderna COVID-19 vaccine has been associated with rare cases of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart), particularly in males aged 12 to 24 years. The FDA has required updates to the prescribing information to include safety information about these risks. It is important to note that continuous monitoring and assessment of the safety of all vaccines, including the Moderna COVID-19 vaccine, is a priority for the FDA.
The FDA has also stated that manufacturers of vaccines authorised under an EUA, such as Moderna, are expected to continue their clinical trials to obtain additional safety and effectiveness information and pursue full approval. This includes conducting studies to assess the potential long-term heart effects in individuals who have experienced myocarditis after receiving the vaccine.
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Emergency Use Authorization (EUA)
An Emergency Use Authorization (EUA) is an authorization granted to the Food and Drug Administration (FDA) to allow the use of an unapproved drug or the unapproved use of an approved drug during a declared state of emergency. The FDA may issue an EUA when certain criteria are met, including that no adequate, approved, and available alternatives exist. The EUA is different from FDA approval (licensure) in that a vaccine available under an EUA is not approved.
In the context of the COVID-19 pandemic, the FDA has issued EUAs for several vaccines, including the Pfizer-BioNTech COVID-19 Vaccine (now marketed as Comirnaty for individuals 16 years of age and older) and the Moderna COVID-19 Vaccine for individuals 18 years of age and older. These vaccines have met the FDA's rigorous scientific standards for emergency use authorization, and the FDA expects manufacturers to continue their clinical trials to obtain additional safety and effectiveness information and pursue approval.
The FDA's decision to issue an EUA for a COVID-19 vaccine is based on a thorough evaluation of all the information included in the manufacturer's submission. This includes safety and effectiveness data, which are discussed by external scientific and public health experts during a public meeting. The FDA also requires recipients of the vaccine under an EUA to be informed of the known and potential benefits and risks, their option to accept or refuse the vaccine, and any available alternatives.
EUAs are temporary and end once the Secretary of Health and Human Services determines that the precipitating emergency has ended or when the product or unapproved use is approved through normal channels. The FDA's ability to issue EUAs is affected by various legislative authorities and presidential executive orders, which may define the situations considered to be public health emergencies.
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Frequently asked questions
Yes, the FDA approved the first COVID-19 vaccine, Pfizer-BioNTech, in the summer of 2021. It later approved the Moderna vaccine in January 2022.
The EUA allows people to start receiving the vaccine, but the vaccine has not been fully approved by the FDA. In order to grant an EUA, the FDA must determine that a vaccine can effectively prevent infection or disease and that its benefits outweigh potential risks.
The FDA has approved and authorized for emergency use updated COVID-19 vaccines (2024-2025 formula) that include protection against the Omicron variant.
