The FDA and Pfizer’s COVID-19 vaccine have moved through three distinct chapters: emergency authorization in December 2020, full approval as Comirnaty in August 2021, and a sharp narrowing in August 2025 that revoked the emergency use authorization and restricted the updated shot to older adults and people with high-risk conditions. Safety labeling has also changed, with a stronger myocarditis warning added in June 2025, and several lawsuits over the vaccine and its clinical trial data are still working through the courts.
Who Can Get the Pfizer COVID Vaccine Now
As of the FDA’s August 27, 2025 actions, the updated 2025–2026 Pfizer-BioNTech vaccine targeting the LP.8.1 strain is approved for two groups: adults 65 and older, and people ages 5 through 64 who have at least one underlying condition that puts them at high risk for severe COVID-19.1FDA. Pfizer-BioNTech COVID-19 Vaccine
No Pfizer COVID-19 vaccine is currently approved or authorized for children under 5. Children in that age group who previously started a Pfizer series must switch to Moderna to complete vaccination.2CDC. COVID Vaccine Considerations for Healthcare Providers
The same day it approved the updated formula, the FDA revoked the emergency use authorizations that had governed COVID-19 vaccine access since 2020. The revocation was issued under a provision of the Federal Food, Drug, and Cosmetic Act allowing revocation when “appropriate to protect the public health or safety.” The agency cited the availability of approved vaccines for the target populations and widespread immunity, and stated explicitly that “safety concerns were not the basis for FDA’s decision to revoke the EUAs.”3Federal Register. Revocation of Pfizer-BioNTech COVID-19 Vaccine EUA
How the FDA Got Here
The FDA’s advisory panel, the Vaccines and Related Biological Products Advisory Committee, voted 17–4 with one abstention on December 10, 2020, to recommend emergency use authorization for the Pfizer-BioNTech vaccine, and the FDA granted the EUA shortly after.4CNBC. Dr. Archana Chatterjee Explains Her FDA Panel No Vote on Pfizer Covid Vaccine Full approval under the brand name Comirnaty followed on August 23, 2021.5Bloomberg Law. Why a Judge Ordered FDA to Release Covid-19 Vaccine Data
Booster expansion was more contested. On September 17, 2021, the advisory committee rejected a broad booster authorization for everyone 16 and older by a vote of 16–2, but unanimously endorsed a narrower booster for people 65 and older and those at high risk. Committee members cited concerns about the quality and quantity of Pfizer’s data for younger populations.6Politico. Tensions Rise as FDA Advisory Panel Weighs Evidence on Pfizer Booster That older-and-high-risk framing largely mirrors the framework the FDA has now made permanent.
The Myocarditis Warning
The most significant post-market safety finding for the Pfizer vaccine has been myocarditis and pericarditis, particularly in younger males. On June 25, 2025, the FDA approved a required updated warning in the labeling of mRNA COVID-19 vaccines. The updated label states that the risk is highest in males 12 through 24 years of age, with an estimated incidence of approximately 27 cases per million doses in that group, compared with roughly 8 cases per million doses across all individuals 6 months through 64 years old.7FDA. FDA Approves Required Updated Warning Labeling mRNA COVID-19 Vaccines Regarding Myocarditis
The updated labeling also included results from a longitudinal study showing that persistence of abnormal cardiac MRI findings was “common” at a median follow-up of about five months after vaccination, though the clinical significance of those findings remains unknown. The FDA requires Pfizer to conduct ongoing studies of potential long-term heart effects in people who developed myocarditis after vaccination.7FDA. FDA Approves Required Updated Warning Labeling mRNA COVID-19 Vaccines Regarding Myocarditis Surveys of patients diagnosed with post-vaccination myocarditis indicate that about 80% were considered by their cardiologists to have fully or probably fully recovered, with longer-term follow-up still pending.8CDC. COVID-19 Vaccine Safety
Broader safety surveillance has produced fewer definitive signals. Early near-real-time monitoring of Medicare recipients 65 and older flagged four potential signals for the Pfizer vaccine (pulmonary embolism, acute myocardial infarction, immune thrombocytopenia, and disseminated intravascular coagulation), but the FDA cautioned these “may not be true safety concerns” and were not replicated in other systems. As of late 2022, the FDA said it had “not found any new causal relationships” between the Pfizer vaccine and those events.9FDA. Initial Results Near Real-Time Safety Monitoring COVID-19 Vaccines Persons Aged 65 Years and Older
The Fight Over Clinical Trial Data
Shortly after Comirnaty’s full approval, a group called Public Health and Medical Professionals for Transparency filed a Freedom of Information Act request for the data Pfizer submitted to the FDA. The agency proposed releasing 500 pages per month, a pace that would have taken an estimated 55 to 75 years to complete production of more than 300,000 pages.10MedPage Today. FOIA Litigation and Pfizer Clinical Trial Data
On January 6, 2022, U.S. District Judge Mark Pittman in the Northern District of Texas rejected that timeline and ordered the FDA to release documents at 55,000 pages per month.5Bloomberg Law. Why a Judge Ordered FDA to Release Covid-19 Vaccine Data As of January 2025, production was still ongoing. Judge Pittman ordered the FDA to produce the remaining Emergency Use Authorization file by June 30, 2025, and denied the agency’s motion to alter the schedule.11Department of Justice. Pub. Health and Med. Pros. for Transparency v. FDA Released documents include de-identified clinical trial patient data, FDA responses to Pfizer’s fast-track review requests, and postmarketing safety data.10MedPage Today. FOIA Litigation and Pfizer Clinical Trial Data
Lawsuits Against Pfizer
Texas Attorney General
In November 2023, Texas Attorney General Ken Paxton sued Pfizer under the Texas Deceptive Trade Practices Act, alleging that the company misrepresented vaccine efficacy by touting a “95% efficacy” figure based on relative risk reduction from a two-month trial, withheld information about durability of protection, failed to measure whether the vaccine prevented transmission, and conspired to censor critics.12Texas Attorney General. Attorney General Ken Paxton Sues Pfizer for Misrepresenting COVID-19 Vaccine Efficacy
On December 30, 2024, Senior U.S. District Judge Sam Cummings in Lubbock dismissed the case, ruling that Pfizer was immune under the Public Readiness and Emergency Preparedness (PREP) Act and that the challenged statements were not connected to trade, commerce, or consumer transactions.13Bloomberg Law. Pfizer Defeats Texas Lawsuit Over Covid Vaccine Effectiveness Texas has appealed to the Fifth Circuit, where the case is pending under docket number 25-10182.14U.S. Chamber of Commerce. Texas v. Pfizer Inc.
Kansas Attorney General
Kansas Attorney General Kris Kobach filed suit in June 2024, alleging violations of the Kansas Consumer Protection Act. The complaint accuses Pfizer of making false statements about vaccine safety and efficacy, including claims that the vaccine was safe for pregnant women and posed no risk of myocarditis or pericarditis. Pfizer removed the case to federal court, but in May 2025 U.S. District Judge Daniel Crabtree granted Kansas’s motion to remand the case back to state court.15Kansas Attorney General. Kansas vs. Pfizer Lawsuit
Brook Jackson Whistleblower Case
Brook Jackson, a former regional director at Pfizer contractor Ventavia Research Group, filed a False Claims Act suit alleging that protocol violations during the vaccine clinical trials amounted to fraud against the federal government. On August 9, 2024, a U.S. District Court in the Eastern District of Texas dismissed the case after the federal government intervened and moved to dismiss. The False Claims Act counts were dismissed with prejudice as to Jackson and without prejudice as to the government.16FindLaw. United States ex rel. Brook Jackson v. Ventavia Research Group The court found that the government’s reasoning constituted a “reasonable argument” for dismissal.17Bloomberg Law. Pfizer Defeats Whistleblower Suit Over Covid-19 Clinical Trial Jackson has appealed, and the case is pending before the Fifth Circuit under case number 24-40564.18Supreme Court. Application for Extension to File Cert Petition
New Regulatory Standards and the ACIP Fight
The August 2025 narrowing was part of a broader shift under Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary. In a May 2025 editorial in the New England Journal of Medicine, Makary and top vaccine official Vinay Prasad wrote that the benefits of repeat doses for healthy individuals remain “uncertain.” The agency now requires randomized, placebo-controlled data on clinical outcomes before clearing COVID shots for healthy children and adults 65 and under, while allowing immunogenicity data alone for high-risk groups.19BioPharma Dive. FDA Covid Booster Approval Framework Makary Prasad NEJM
HHS has also announced that all “new vaccines” must undergo placebo-controlled trials before licensure and classified updated COVID-19 vaccines as new products rather than routine strain updates. Dr. Paul Offit warned that requiring such trials would delay updated COVID shots by months and endanger vulnerable populations.20CNN. HHS Vaccine Placebo Testing The Infectious Diseases Society of America said the narrowed approvals “completely contradicts the evidence base, severely undermines trust in science-driven policy and dangerously limits vaccine access.”21BioPharma Dive. Covid Booster FDA Approval Limits Kennedy Pfizer Moderna
On June 9, 2025, Kennedy fired all 17 members of the Advisory Committee on Immunization Practices and replaced them with a smaller panel. A court later found that of the 15 members seated at the time of its ruling, only 6 had meaningful vaccine-related experience, while at least 6 lacked any such expertise. At its September 2025 meeting, the reconstituted committee voted to downgrade the COVID-19 vaccine recommendation from “routine” to “shared clinical decision making.”22Georgetown University CCF. Court Order Presses Pause on New ACIP Committee and Changes to Childhood Vaccination Schedule
Those changes are now in litigation. On March 16, 2026, Judge Brian E. Murphy of the U.S. District Court for the District of Massachusetts issued a preliminary injunction temporarily blocking the administration’s changes to the childhood immunization schedule, the reconstituted ACIP’s decisions, and Kennedy’s appointments to the committee.23CIDRAP. Federal Judge Blocks Kennedy’s Changes to Childhood Vaccine Policy Fifteen states, including California, Maryland, Michigan, and New Jersey, filed a separate lawsuit in February 2026 challenging the “Kennedy Schedule” and the ACIP appointments as unlawful.24Office of the Attorney General of Maryland. Attorney General Brown Joins Multistate Lawsuit As of mid-2026, ACIP is described as being in “legal limbo” with no functioning recommending body, creating confusion for pharmacies and clinicians about who should receive vaccines.25CIDRAP. State of US Vaccine Policy
The FDA’s approval of the Pfizer shot for adults 65+ and people 5–64 with high-risk conditions remains in place regardless of the ACIP dispute. Access questions at the pharmacy counter, including who a pharmacist will vaccinate without a prescription and how insurance covers the dose, depend on state rules and are unsettled while the ACIP litigation is pending.