Chloe Ramirez
The COVID-19 vaccines have been a topic of discussion and debate since their inception. The Food and Drug Administration (FDA) approved the first COVID-19 vaccine, Pfizer-BioNTech, in 2021, and later approved the Moderna vaccine in 2022. The FDA has also issued Emergency Use Authorization (EUA) for several vaccines, including the Pfizer-BioNTech, Moderna, and Johnson & Johnson vaccines. The FDA closely monitors the safety of all vaccines and has recently approved updated warning labels for mRNA COVID-19 vaccines regarding myocarditis and pericarditis. The 2024-2025 COVID-19 vaccine is now available and recommended for everyone over the age of five.
| Characteristics | Values |
|---|---|
| Number of vaccines with FDA approval | More than 80 |
| Diseases with FDA-approved vaccines | Influenza, smallpox, COVID-19 |
| Agencies responsible for vaccine approval in the US | The Centers for Disease Control and Prevention (CDC), the U.S. Food and Drug Administration (FDA) |
| Approval process | Facility inspections, human trials |
| Time taken for approval | Several years |
| FDA-approved prescribing information | Indications and usage, dosage and administration, contraindications, warnings and precautions, adverse reactions, drug interactions, use in specific populations, clinical studies, storage and handling, patient counseling information |
| FDA-approved vaccines | Comirnaty, Spikevax, Moderna COVID-19 Vaccine, Pfizer-BioNTech COVID-19 Vaccine |
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What You'll Learn
The FDA approval process
In the United States, the FDA (U.S. Food and Drug Administration) is responsible for determining whether individual vaccines should be authorized for use. The FDA approval process is designed to ensure that vaccines are safe and provide the protection they are supposed to. The process typically takes several years and involves everything from facility inspections to human trials.
The FDA's Center for Drug Evaluation and Research (CDER) oversees the drug approval process before a drug is marketed. CDER ensures that both brand and generic drugs work correctly and that their health benefits outweigh their known risks. They review each drug closely using an independent team of clinicians and scientists who evaluate the safety, efficacy, and labeling of the drug product. After new drug approval, the FDA continues to monitor the drug to ensure it remains safe and effective. The full research, development, and approval process can last from 12 to 15 years.
In the early phases of drug development, manufacturers conduct preclinical research, which involves testing a drug candidate for toxicity in animals before moving on to human trials. The FDA employs several approaches to encourage the development of certain drugs, especially those that may represent the first available treatment for an illness or offer significant benefits over existing treatments. These approaches include Accelerated Approval, which allows promising therapies for serious or life-threatening conditions to come to market more quickly, and Breakthrough Therapy, where preliminary clinical research demonstrates that a drug candidate may provide substantial improvement over available therapy.
The FDA also offers a Fast Track designation to facilitate the development and review of drugs that treat serious conditions and fill an unmet medical need, based on promising animal or human data. Additionally, companies can pay for an expedited NDA review through the Prescription Drug User Fee Act (PDUFA), which allows the FDA to access more resources to speed up the drug approval process.
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The CDC and FDA's roles
In the United States, the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are the two federal agencies responsible for ensuring vaccine safety. The FDA is responsible for determining whether vaccines should be authorized for use in the United States. It does this through an approval process that involves facility inspections and human trials. The CDC, on the other hand, provides vaccine recommendations and general oversight regarding vaccine safety. It only recommends vaccines that have received FDA approval.
Once the FDA authorizes or licenses a vaccine, recommendations for its use are developed by the Advisory Committee on Immunization Practices (ACIP). The ACIP is an external advisory committee that advises the CDC director on the use of vaccines in the civilian population. The CDC adopts these recommendations, and they must be covered at no cost by most health plans per the Affordable Care Act. The FDA and CDC also collaborate with other federal agencies and programs that play a role in vaccine development and use, including the National Institutes of Health, the Health Resources and Services Administration, and the Center for the Biomedical Advanced Research and Development Authority (BARDA).
After a vaccine is licensed or authorized, the FDA and CDC continue to monitor vaccine safety through surveillance programs such as the Vaccine Adverse Event Reporting System, the Vaccine Safety Datalink, and the Clinical Immunization Safety Assessment Project. These programs help address concerns about adverse events after vaccination, which have received greater attention as diseases prevented by vaccines become less common.
The FDA and CDC's roles in vaccine policy are influenced by the Department of Health and Human Services (HHS). The HHS Secretary oversees the FDA and CDC and has the authority to overrule their decisions and recommendations. They can also influence federal vaccine policy by determining advisory committee memberships and making staffing decisions within certain limits.
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FDA-approved COVID-19 vaccines
In the United States, the FDA is responsible for determining whether individual vaccines should be authorized for use. The FDA approval process typically takes several years and involves facility inspections and human trials.
The first COVID-19 vaccine approved by the FDA was the Pfizer-BioNTech COVID-19 vaccine, now marketed as Comirnaty. Comirnaty is approved for individuals 16 years of age and older. The FDA has also approved updated mRNA COVID-19 vaccines for 2024-2025 to better protect against currently circulating variants. These include the Moderna COVID-19 vaccine, approved for individuals 6 months through 11 years of age, and the Pfizer-BioNTech COVID-19 vaccine, approved for the same age group. The Novavax COVID-19 vaccine, for individuals 12 years of age and older, has also been authorized to better protect against circulating variants.
The CDC recommends COVID-19 vaccination for everyone aged 6 months and older, including pregnant, breastfeeding, or potentially pregnant women. The FDA-approved vaccines, Comirnaty and Spikevax, contain messenger RNA (mRNA), a type of genetic material used by the body to create a mimic of one of the proteins in the virus that causes COVID-19. The approval of these vaccines is a significant milestone in the battle against the COVID-19 pandemic, providing the public with increased confidence in the safety and effectiveness of the vaccines.
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FDA-approved prescribing information
In the United States, the FDA is responsible for determining whether vaccines should be authorized for use. The FDA approval process is designed to ensure that vaccines are safe and provide the necessary protection. The FDA maintains an updated list of approved vaccines on its website. Currently, there are over 80 vaccines that have received FDA approval.
The FDA-approved prescribing information for vaccines includes detailed instructions for healthcare providers to ensure safe and effective use. This information is commonly referred to as the "package insert". It covers:
- Indications and usage
- Dosage and administration
- Contraindications
- Warnings and precautions
- Adverse reactions
- Observed or predicted clinically significant interactions with drugs, including other vaccines
- Use in specific populations
- Clinical studies
- Storage and handling
- Patient counselling information
The prescribing information is based on scientific data submitted by the manufacturer in a biologics license application. It is reviewed by the CBER, which is responsible for the regulatory oversight of vaccine development and the licensure of new vaccines. The information is updated as needed to include the most current information about the vaccine.
The FDA closely monitors the safety of all vaccines during post-market use. For example, the FDA approved updated warnings in the prescribing information for the mRNA COVID-19 vaccines Comirnaty and Spikevax regarding the risks of myocarditis and pericarditis following vaccination. The FDA has also approved updated COVID-19 vaccines for the 2024-2025 formula to provide better protection against circulating variants.
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FDA-approved vaccines: past and present
In the United States, the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) are the two federal agencies responsible for ensuring vaccine safety. The CDC provides vaccine recommendations and general oversight, while the FDA determines whether individual vaccines should be authorized for use in the United States. To be offered for sale in the U.S., vaccines must go through an approval process with the FDA, which typically takes several years and involves facility inspections and human trials.
There are currently more than 80 vaccines with FDA approval, covering a long list of diseases. These include diseases for which the CDC generally recommends vaccination, such as measles and pertussis, as well as diseases that pose risks for overseas travelers or specific individuals under certain circumstances. For some diseases, there is only one FDA-approved vaccine, while others have multiple vaccine options or even multiple variants recommended for different populations. There are also combination vaccines that provide protection against multiple diseases with a single injection.
The FDA approval process is designed to ensure that vaccines are safe and effective, and approved vaccines undergo rigorous reviews of laboratory and clinical data. Vaccines approved for marketing may also be required to undergo additional studies to further evaluate their safety, effectiveness, and potential side effects.
The history of FDA-approved vaccines dates back to at least 1796, with the earliest analyzed vaccine made available that year. Over time, the number of different pathogens targeted by vaccines has expanded, with a consistent growth in vaccines targeting viral pathogens compared to a plateau in vaccines for bacterial infections.
In the past, there have been instances of vaccine withdrawal due to lack of efficacy or safety concerns. For example, a staphylococcal toxoid vaccine introduced in 1933 was withdrawn in 1954 due to lack of efficacy, and a Lyme disease vaccine introduced in 1998 was withdrawn in 2002 amid questions of toxicity and poor sales.
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Frequently asked questions
Yes, the FDA approves vaccines. In the United States, the FDA and the CDC are responsible for ensuring that vaccines are safe for the public. The FDA has approved more than 80 vaccines, including the COVID-19 vaccines.
The approval process typically takes several years and involves facility inspections and human trials. The FDA evaluates the safety of a vaccine by considering the characteristics of the population receiving the vaccination and the disease(s) it intends to prevent.
The FDA has approved vaccines for smallpox, polio, measles, tetanus, diphtheria, and rubella. There are also more than 10 innovative vaccines for the influenza virus.
The CDC provides vaccine recommendations and general oversight for vaccine safety. They make recommendations for the use of FDA-licensed vaccines, and these recommendations are based on disease epidemiology, public acceptance, vaccine supply, and cost.
The prescribing information addresses indications and usage, dosage and administration, contraindications, warnings and precautions, adverse reactions, drug interactions, use in specific populations, clinical studies, storage and handling, and patient counselling information.
