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COVID-19: FDA Amends Pfizer Vaccine EUA, Agencies Brace for PHE End

The Food and Drug Administration (FDA) on April 28 amended the emergency use authorization (EUA) for the Pfizer-BioNTech bivalent COVID-19 vaccine, authorizing a fourth dose for immunocompromised children aged 6 months to 4 years old who have received three previous doses of either the monovalent vaccine or the bivalent vaccine.

FDA amended the Pfizer EUA on April 18 to include only the bivalent vaccine and simplify the vaccination schedule for most individuals.

National Agencies Brace Americans for End of COVID-19 PHE

On May 1, the Biden administration announced it will end COVID-19 vaccine requirements for federal employees, federal contractors, and international air travelers when the COVID-19 public health emergency (PHE) ends on May 11.

“While vaccination remains one of the most important tools in advancing the health and safety of employees and promoting the efficiency of workplaces, we are now in a different phase of our response when these measures are no longer necessary,” said the statement.

As the end of the PHE looms and deaths from COVID-19 reach a pandemic low, several federal agencies also have announced changes.

The Centers for Disease Control and Prevention (CDC) no longer will update its COVID-19 Community Levels tracker that monitors the spread of the infection, and labs will no longer be required to report COVID-19 testing data to the federal government.

The Centers for Medicare and Medicaid (CMS) issued FAQs on waivers and flexible policies to help prepare for the expiration of the PHE, which clarify access to COVID-19 tests and treatments for beneficiaries of all CMS programs.

CDC: Monovalent Vaccine Effective in Preventing Ventilation, Death

The monovalent COVID-19 vaccine demonstrated effectiveness in preventing invasive mechanical ventilation (IMV) and death between February 2022 and January 2023, according to an April 28 CDC Morbidity and Mortality Weekly Report.

The vaccine was 76 percent effective in preventing IMV and death in the six months following the last monovalent dose and 56 percent effective after one to two years.

Visit the America’s Essential Hospitals coronavirus resource page for more information about the pandemic.

Contact Senior Director of Policy Erin O’Malley at or 202.585.0127 with questions


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