FDA Authorizes Novavax COVID-19 Vaccine

The FDA today authorized the use of a COVID-19 vaccine today that might be more acceptable to people with fears about vaccines that depend on nucleic acids

The new vaccine, manufactured by Novavax, a relatively small biotechnology company in Gaithersburg, Maryland, is made by assembling proteins found in the spikes that jut out from the surface of the SARS-CoV-2 virus.The proteins are combined with an adjuvant that the company’s website says is derived from the bark of Soapbark trees grown in Chile. Adjuvants are ingredients added to some vaccines to provoke a stronger immune response.

In contrast, the Pfizer and Moderna vaccines use messenger RNA to generate proteins that stimulate a vaccine response. RNA, which stands for ribonucleic acid, is not DNA, the molecule that make up genes, but it “reads” DNA to make proteins and consists of nucleic acids (a single strand rather than double one) like DNA.

There has been misinformation about the COVID-19 vaccines altering in some of people's DNA. Short of that belief, some people confuse RNA and DNA and are frightened by the vaccine mRNA shots.

Novavax said in a press release today that doses of its vaccine will be available in the next few days. The Wall Street Journal reported that millions of doses will be available in a few days' time.

Multiple media reports said Novavax will be priced at $130 a dose. The Kaiser Family Foundation says Pfizer and Moderna are charging $115 and $128, respectively. Because of the Affordable Care Act and laws passed during the early years of the COVID-19 pandemic, people with private insurance or coverage through a public insurer such as Medicare and Medicaid don't have to pay anything out-of-pocket for the vaccines. The federal government has stopped buying COVID-19 vaccines so the cost is borne by private and public insurers.

Novavax tinkered with its vaccine so it would protect against the XBB.1.5. variant of the COVID-19 virus that was circulating earlier this year. But other variants have since displaced XXB1.5, including EG.5 (nicknamed Eris) ad BA.2.86 (nicknamed Pirola).

XBB.1.5. and new strains are all descendants of the Omicron variant that started to circulate in late December 2021. All three vaccines are expected to be effective against the new variants. The Novavax press release says that non-clinical data show that its vaccine produced neutralizing antibodies against EG.5, BA.2.86 and other subvariants and “robust” T-cell responses. Some vaccine experts say the T-cell response to vaccines has been underrated in the analysis of their effectiveness.