Skip to content

Federal Approvals Open Doors to New Treatments

July 22, 2022

Thanks to a series of recent FDA approvals, patients of all ages will have the opportunity to benefit from several medical innovations. 

A Different COVID-19 Vaccine

Earlier this week, Novavax received emergency use authorization for people 18 and older to take its COVID-19 vaccine – becoming the fourth option for Americans.

Coronavirus vaccines using mRNA technology have been available since December 2020, but approximately 10% of adults have yet to receive a single dose. The federal government has ordered 3.2 million doses of the new vaccine, hopeful that some skeptics of the mRNA shots will roll up their sleeves for this one because it’s built on a different technology.

Expanded Label for Chronic Gout Medication

Pegloticase, the only FDA approved biologic for uncontrolled gout, has been hailed lifechanging for people who struggle to manage their chronic gout. Despite the medication’s effectiveness for most patients, a small but meaningful percentage of patients weren’t seeing the same results. Now, those patients have a new option: pegloticase co-administered with methotrexate.

Clinical trial participants with uncontrolled gout were found to more fully respond when taking the combination of medications. The number of patients who experience infusion reactions also decreased. This is just the first of many new gout treatments that are expected to come to market soon.

Vaccine to Protect Infants and Children Against Pneumococcal Disease

As of last month, infants and children from six weeks through 17 years have an approved vaccine that can protect them against pneumococcal bacteria, which can cause pneumonia, meningitis and blood infections.

Children are not only eligible for the new vaccine, but recommended to get it by the CDC’s Advisory Committee on Immunization Practices. The vaccine, which was given priority review, requires a four-shot series to be fully protected against diseases in the pneumococcal family.

Education and Access

Federal approval is just the first step to patients being helped by medical innovations. Ensuring patients, their doctors and loved ones know about new medications is necessary. So, too, are policies and programs that enhance access.

The federal government, for example, requires COVID-19 vaccines to be free for everyone in the United States. And the ACIP recommended the pneumococcal disease vaccine be included in the federally funded Vaccines for Children Program, which provides shots at no cost to children who run the risk of not being vaccinated due to lack of insurance or financial resources.

Beyond free programs, federal policymakers also have the authority to enact laws that support patient access and prohibit overly restrictive insurance barriers that keep patients from realizing the benefits of even the newest medical innovations.