Timeline of Key Events:
Timeline of Key Events: Pharmacies’ Role in Advancing Access to COVID-19 Countermeasures, Including Vaccine & Testing
March 2020
- HHS Secretary’s PREP Act Declaration for the manufacture, distribution, administration, or use of medical countermeasures.
April 2020
- HHS Guidance authorizes pharmacists nationwide to order and administer COVID-19 tests.
May 2020
- HHS initiated partnership for pharmacy-based COVID-19 testing, beginning with 362 live sites across 45 states and District of Columbia (DC).
June 2020
- Pharmacy testing sites increased to 623 sites in 48 states, DC, and Puerto Rico, with over 700,000 samples processed.
August 2020
- PREP Act – Third Amendment is issued authorizing pharmacists nationwide to order and administer all routinely recommended vaccines for 3-18-year-olds.
September 2020
- HHS Guidance authorizes pharmacists nationwide to order and administer COVID-19 vaccines to persons 3 years and older.
October 2020
- HHS Guidance authorizes pharmacy technicians to administer childhood vaccines, COVID vaccines, and COVID-19 tests.
- HHS Guidance clarifies that PREP Act authorizations preempt state or local restrictions.
- CDC issued specific guidance to jurisdictions advising them to include pharmacies as early COVID-19 vaccination providers.
- State/Jurisdiction-Level Program(s)/Partnership(s) for COVID-19 Vaccination allowed pharmacies to enroll directly in a jurisdiction’s COVID-19 vaccination program.
- Federal Pharmacy Partnership for Long-Term Care (LTC) Program was established by CDC.
November 2020
- HHS released a list of participating pharmacy companies in what would come to be known as the Federal Retail Pharmacy Program for COVID-19 Vaccination.
December 2020
- FDA authorizes the Pfizer-BioNTech and Moderna COVID-19 vaccines for individuals 16 and 18 years of age, respectively.
- PREP Act – Fourth Amendment clarifies the training requirements for licensed pharmacists.
- CDC’s ACIP recommended that the first COVID vaccines should be targeted to both healthcare personnel and residents of long-term care facilities.
- After that recommendation was released, NACDS called for the federal government to “turn on the Federal Pharmacy Partnership Program to enable vaccination of the millions of people in these target populations.”
- The federal government provided most of the limited supply of vaccine doses to states and jurisdictions and began a vaccine distribution program to selected pharmacies targeting residents and staff in LTC facilities.
- Federal Pharmacy Partnership for Long-Term Care (LTC) Program began providing on-site vaccinations for LTC and assisted living facility residents and staff on December 21, 2020.
January 2021
- CDC issued funding and guidance for all jurisdictions and included as its first recommendation to jurisdictions “increase the number of vaccine provider sites, including through the use of pharmacies.”
- Federal pharmacy testing sites increased to 3,300 locations across all 50 states, DC, and Puerto Rico, with more than 5.6 million samples tested. Over 70% of pharmacy sites within the program located in communities with moderate-to-high social vulnerability.
February 2021
- FDA issued EUA for Janssen’s single-dose COVID-19 vaccine for individuals 18 years of age and older.
- Federal Retail Pharmacy Program for COVID-19 Vaccination was launched by CDC in February 2021 as a “a key part of its COVID-19 vaccination strategy” with 21 national pharmacy partners and networks of independent pharmacies, representing over 41,000 pharmacy locations nationwide.
- Federal Transfer Program with Jurisdiction(s) for COVID-19 Vaccination allowed states to transfer allocated vaccine doses to federal pharmacy partners.
March 2021
- PREP Act – Seventh Amendment authorizes pharmacists with recently inactive, expired, or lapsed licenses to prescribe, dispense, and/or administer COVID vaccines.
- Federal pharmacy testing sites increased to 6,211 locations across all 50 states, DC, and Puerto Rico with over 9.8 million samples processed.
April 2021
- CDC issued further guidance and funding to jurisdictions urging them to “Improve access to COVID-19 vaccines” by “using multiple types of locations and with flexible hours that are accessible to and frequented by the identified communities of focus” including pharmacies.
- CDC and FDA recommended a pause in the use of the Janssen vaccine to review data involving six reported U.S. cases of a rare and severe type of blood clot. The pause was lifted on April 23, 2021 following a safety review and revisions to the vaccine fact sheet.
May 2021
- FDA expanded the EUA for the Pfizer-BioNTech COVID-19 vaccine to include adolescents 12 through 15 years of age.
August 2021
- PREP Act – Eight Amendment expands the scope of authority for qualified pharmacy technicians to administer seasonal influenza vaccines to adults.
- FDA amended the EUAs and CDC endorsed the ACIP recommendation for both Pfizer-BioNTech and the Moderna COVID-19 vaccines for an additional dose for people with moderately to severely compromised immune systems after an initial two-dose vaccine series.
September 2021
- PREP Act – Ninth Amendment expands the scope of authority for pharmacists to order and administer select COVID 19 therapeutics and for pharmacy technicians to administer COVID-19 therapeutics.
- FDA amended the EUA and CDC endorsed the ACIP recommendation for the Pfizer-BioNTech COVID-19 vaccine for a single booster dose, to be administered at least six months after completion of the primary series in certain populations.
- President Biden’s COVID-19 Action Plan outlines plans to expand the Federal pharmacy testing program to 10,000 pharmacies.
October 2021
- FDA authorized the emergency use and CDC endorsed the ACIP recommendation of the Pfizer-BioNTech pediatric COVID-19 vaccine for children 5 through 11 years of age.
- FDA expanded the use of a booster dose and CDC recommended expanded eligibility for COVID-19 vaccine boosters for all adults who received a Janssen COVID-19 vaccine and certain adults who received the Moderna vaccine and approved using different booster products than the primary series, “mix-and-match”.
- President Biden committed to doubling the number of pharmacies within the federal testing program from 10,000 to 20,000.
November 2021
- FDA amended the emergency use authorizations for both the Moderna and Pfizer-BioNTech COVID-19 vaccines authorizing use of a single booster dose for all individuals 18 years of age and older after completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine.
- CDC also endorsed the CDC ACIP’s expanded recommendations for booster shots to include all adults ages 18 years and older who received a Pfizer-BioNTech or Moderna vaccine at least six months after their second dose.
- FDA’s Antimicrobial Drugs Advisory Committee Meeting was held to discuss an EUA submitted by Merck & Co. Inc., for emergency use of molnupiravir oral capsules for treatment of mild to moderate COVID-19 in adults. While the EUA has not yet been issued, the committee voted in favor of the product. The US government is purchasing more than 3 million courses.
- Pfizer requested FDA emergency use authorization for its COVID-19 antiviral pill, Paxlovid, on November 16, 2021. The US government is purchasing 10 million courses of this product.
