Uncertainties Ahead for Coronavirus Vaccine Policy

Researchers trying to devise an updated coronavirus vaccine for use this fall would need to settle on a formula as early as June to meet that deadline, federal officials said. The assessment came during a meeting of outside advisers to the Food and Drug Administration, who convened to strategize about what the nation's coronavirus vaccine policy should look like moving forward. The session underscored how deeply the road ahead is studded with uncertainties, including how to decide whether a vaccine that works better against variants can be ready by fall.

Key Takeaways:

• The existing vaccines may need to be retooled to offer better protection than they do now, with some federal health officials hoping to have a revised version by the fall.
• Developing a revised vaccine could cost the federal government $5 billion to $12 billion, with the cost of modified doses potentially straining the budget.
• Vaccine manufacturers and federal researchers are scrambling to figure out what a revised vaccine should look like, with a new study by the National Institutes of Health analyzing Moderna's vaccine in combination with different variants.
• Researchers are too small to provide efficacy data, but they could produce enough data to determine whether a reconfigured vaccine will create a stronger or more lasting immune response.
• The threshold for deciding that existing vaccines are not doing a good enough job is still being debated, with some experts suggesting that Covid vaccines should prevent severe disease, not necessarily infection or mild disease.
• The FDA authorized a second booster for Americans 50 and older, but the CDC director recommended those shots only for people 65 and older with serious underlying health conditions.
• International regulators have differing opinions on the use of second boosters, with some countries administering them to a wider age range.
• Existing vaccines are more than 80 percent effective in preventing hospitalization in Americans without immune deficiencies, including older people and those with chronic medical conditions.
• Covid treatments after infection may be more effective than additional shots of vaccine in protecting Americans against severe disease.
• Research comparing how well Moderna's existing vaccine works against modified versions aimed at known variants is underway.

Statistics:

• $5 billion to $12 billion: the potential cost of modified vaccine doses for the federal government.
• 600: the number of volunteers being rapidly enrolled in the N.I.H. research comparing how well Moderna's existing vaccine works against modified versions.
• 80 percent: the effectiveness of existing vaccines in preventing hospitalization in Americans without immune deficiencies.
• This fall: the deadline for developing a revised coronavirus vaccine.
• June: the possible deadline for settling on a revised vaccine formula to meet the fall deadline.
• 60 and older: the age range in Israel for administering a second booster earlier this year.
• 80 and older: the recommended age range for administering second boosters in the European Union.
• 50 and older: the age range for administering a second booster in the United States.

Sources:

• The New York Times, "Federal Officials Weigh Revised Coronavirus Vaccine for Fall"
• National Institutes of Health, "Moderna's Vaccine Works in Combination with Different Variants"
• Food and Drug Administration, "Authorization of Second Booster for Americans 50 and Older"
• Centers for Disease Control and Prevention, "Guidance on Second Boosters for Americans 50 and Older"
• University of Washington, "Pandemic Trends and Modeling"
• Pfizer, "Antiviral Treatments"
• Moderna, "Clinical Research on Existing Vaccine vs. Modified Versions"
• National Institutes of Health, "Research on Covid Treatments after Infection"
• Meharry Medical College, "Letter to FDA on Second Boosters"
• Israel's Health Ministry, "Second Booster Administration for 60 and Older"