FDA and CDC Provide Strong Support for Novavax’s Enhanced Covid Vaccine Update

Novavax‘s updated Covid vaccine secured the endorsement of U.S. regulators on Tuesday, positioning the shot for release shortly after new vaccinations from Pfizer and Moderna already reached the American population.

The approval from the Food and Drug Administration (FDA) allows Novavax’s single-strain vaccine, which targets omicron subvariant XBB.1.5, to be used in emergency situations for individuals aged 12 and above.

The Centers for Disease Control and Prevention (CDC) has now included Novavax’s vaccine in its updated recommendations, alongside the vaccines from Pfizer and Moderna. These recommendations state that all individuals aged six months and older are eligible to receive an updated Covid vaccine.

Novavax has announced that doses of their vaccine will likely become available in the next few days.

“Novavax’s authorization today means people will now have the choice of a protein-based non-MRNA option to help protect themselves against Covid-19, which is now the fourth leading cause of death in the U.S.,” said John Jacobs, CEO of Novavax. “In the coming days, individuals in the U.S. can go to major pharmacies, physicians’ offices, clinics, and various government entities to receive the updated Novavax vaccine.”

Public health officials view Novavax’s vaccine as an important alternative for individuals who prefer not to receive messenger RNA shots from Pfizer and Moderna. Novavax’s protein-based technology has been used for routine vaccinations against diseases like hepatitis B and shingles for decades.

According to the Biden administration, approximately 2 million Americans have already received the updated Covid vaccines from Pfizer and Moderna. However, some individuals have experienced insurance delays and availability issues when attempting to receive their doses.

Nevertheless, all three vaccines are expected to aid in the fight against the spread of Covid during the fall and winter seasons when virus transmission rates are typically higher.

The U.S. is currently witnessing a surge in cases and hospitalizations, though the levels remain lower than previous waves. This resurgence has led to the reinstatement of mask mandates in certain business establishments and schools.

This increase in cases is primarily driven by new strains of the virus, with XBB.1.5 gradually declining and strains like EG.5 (Eris) becoming more prevalent. As of Saturday, EG.5 accounted for approximately 29.4% of all cases, according to the CDC.

Novavax has stated that its new Covid vaccine generates a robust immune response against Eris and another fast-spreading variant, XBB.1.16.6. However, it remains uncertain whether the vaccine will protect against BA.2.86, a highly mutated omicron strain being closely monitored by health officials.

The release of Novavax’s new vaccine comes months after the end of the U.S. Covid public health emergency. Consequently, all three vaccine manufacturers will now sell their updated shots directly to healthcare providers and compete for market share.

During an advisory meeting last month, Novavax revealed that the list price of their vaccine is $130 per dose.

To ensure access for uninsured individuals, federal and corporate programs are working to fill the gaps. One such program is the Biden administration’s Bridge Access Program, which offers free Covid vaccines to the underinsured and uninsured.

It remains uncertain how many Americans will choose to receive the new vaccines from Novavax, Pfizer, and Moderna. However, a CDC survey conducted in August found that approximately 42% of Americans stated they would “definitely” or “probably” get a Covid vaccine in the fall.