The committee will vote on whether the benefits of the two-dose vaccine outweigh the risks for ages 18 and older, according to the 80-page briefing document posted Friday.

Based on data included in the document, an FDA review found that the vaccine’s effectiveness was 90.4% overall against mild, moderate, or severe COVID-19 for about 2.5 months after completing the two doses. For adults 65 and older, effectiveness fell to 78.6%.

These numbers were collected before the emergence of the Omicron variant, according to CNN. It remains unclear how effective the vaccine is or how long protection lasts against the most recent subvariants.

Novavax has reported that its vaccine has “broad cross-creativity against Omicron and other circulating variants from a primary 2-dose regimen, with responses that increased following a third dose at six months,” according to an announcement released in late December.

The FDA will also consider reports of adverse reactions to the Novavax vaccine, including fatigue, headaches, muscle aches, and pain at the injection site. Most reports were of mild to moderate reactions that lasted a few days. However, the FDA described rare events of myocarditis and pericarditis, which involve inflammation of the heart muscle and tissue surrounding the heart.

The briefing document describes six cases of myocarditis or pericarditis that happened after the Novavax vaccine. Five were among males between ages 16-67. Among the six cases, five were hospitalized but have now recovered.

Novavax addressed the heart inflammation concerns in a statement on Friday, saying that the rate of myocarditis is “within the expected rate” and similar to the groups that received a placebo. The company added there is “insufficient evidence” to establish a causal relationship between the vaccine and myocarditis or pericarditis.

“We have learned that we can expect to see natural background events of myocarditis in any sufficiently large database, and that young males are at higher risk,” the company said. “Myocarditis is most often caused by nonspecific viral infections.”