FDA approves next dose of COVID-19 vaccine

April 2, 2022 — On Monday, the Food and Drug Administration (FDA) authorized a second booster dose of both the Pfizer-BioNTech and the Moderna COVID-19 vaccines for those over 50 years old or with extenuating health situations. 

According to Lane County Health & Human Services Public Information Officer Jason Davis, “Dr. Patrick Luedtke (Lane County's Senior Public Health Officer) just signed the orders. The second dose is available as of (March 31). Newsflash, you should be able to get it at any pharmacy. All those pharmacies are operating under Luedtke’s standing orders. Every pharmacy in Lane County is able to give the second booster if they have supply enough to do so. And we will be offering to Autzen Stadium and any of the Lane County clinics going forward.”

People can learn more at lanecounty.org/vaxclinics or by calling 541-682-1380.    

Emerging evidence suggests a second booster will provide significant additional protection against emerging strains of the coronavirus and for those with increased risks due to a wide variety of underlying health concerns.

The FDA amended the current emergency authorization to say, “A second booster dose of the Pfizer-BioNTech COVID-19 Vaccine or Moderna COVID-19 Vaccine may be administered to individuals 50 years of age and older at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine.”

In addition, a second booster dose may be administered to individuals 12 years of age and older with certain kinds of immunocompromise, again at least 4 months after receipt of a first booster dose.

A second booster dose may be administered at least 4 months after the first booster dose of any authorized or approved COVID-19 vaccine to individuals 18 years of age and older with the same certain kinds of immunocompromise.

“Current evidence suggests some waning of protection over time against serious outcomes from COVID-19 in older and immunocompromised individuals. Based on an analysis of emerging data, a second booster dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine could help increase protection levels for these higher-risk individuals,” said Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research. “Additionally, the data show that an initial booster dose is critical in helping to protect all adults from the potentially severe outcomes of COVID-19. So, those who have not received their initial booster dose are strongly encouraged to do so.”

Oregon Health Authority (OHA) officials say the state has plenty of COVID-19 vaccine supply to meet increased demand that may occur after federal agencies authorized the second booster doses.

OHA also updated and distributed its standing immunization protocols for vaccine providers after the FDA and the CDC and the Western States Scientific Safety Review Workgroup on Tuesday approved and recommended allowing older and immunocompromised persons to get another booster. The Western States Scientific Safety Review Workgroup includes Oregon, California, Nevada and Washington.

According to the protocols, individuals in these groups who received an initial booster dose at least four months ago can now get a second booster dose of the two available mRNA vaccines — made by Pfizer-BioNTech and Moderna — to increase their protection against severe disease from COVID-19. Adults who received a primary vaccine and booster dose of Johnson & Johnson’s Janssen COVID-19 vaccine at least four months ago also can now receive a second booster dose using an mRNA COVID-19 vaccine.

OHA officials say there’s more than enough vaccine supply in Oregon to accommodate the new groups eligible for second boosters. 

About 270,000 doses of Pfizer and Moderna are distributed throughout the state, which should easily meet any surge in demand. And new demand should help providers use up some of their excess vaccine stocks.

In addition, Oregon has plenty of allocation from CDC planned to meet increased demand as well, though vaccine orders aren’t expected to increase much given how much vaccine is already available at provider offices.

“I’m not worried about vaccine supply right now, even if we see a rush for second boosters following this week’s news,” said Paul Cieslak, M.D., medical director for communicable diseases and immunizations in OHA’s Public Health Division. “Existing supply is already strong, and the CDC is ready to send more doses if we need them.”

OHA’s vaccine data dashboards show that of the roughly 1.6 million people older than 50 in Oregon, about 893,000, or 56%, got their initial booster. Using that same proportion to estimate those who will seek an additional booster, OHA anticipates that 500,000 second boosters may be given in Oregon over about the next four to six months.

Vaccines are available to people in Oregon through health care providers, local pharmacies and high-volume vaccination and testing sites.

OHA strongly encourages everyone eligible in Oregon to get their primary doses of the COVID-19 vaccines followed by a booster shot. Those most at risk for the virus are people who have not yet received a primary series of the vaccines.

The agency will continue to evaluate data and information as it becomes available when considering the potential use of a second booster dose in other age groups. 

The CDC statement on the decision to authorize the second booster came from CDC Director Rochelle Walensky.

“Today, CDC expanded eligibility for an additional booster dose for certain individuals who may be at higher risk of severe outcomes from COVID-19. Boosters are safe, and people over the age of 50 can now get an additional booster 4 months after their prior dose to increase their protection further. This is especially important for those 65 and older and those 50 and older with underlying medical conditions that increase their risk for severe disease from COVID-19 as they are the most likely to benefit from receiving an additional booster dose at this time. CDC, in collaboration with FDA and our public health partners, will continue to evaluate the need for additional booster doses for all Americans.”

For more information, visit healthoregon.org/coronavirus.