FDA clears Novavax Covid vaccine for adults


In this photo illustration, the Food and Drug Administration (FDA) and Novavax logos are seen behind a medical syringe and vials.

Pavlo Gonchar | Light flare | Getty Images

The Food and Drug Administration has cleared the two-dose Novavax vaccine for adults 18 and older, the fourth Covid vaccine to gain emergency approval in the United States since the pandemic began.

The FDA’s decision comes weeks after its committee of independent vaccine experts voted overwhelmingly in favor of Novavax’s vaccine in early June, following a day-long public meeting where they assessed the data. on the safety of the vaccine and its effectiveness in preventing Covid disease.

The Centers for Disease Control and Prevention must still approve Novavax’s vaccine before pharmacies and other health care providers can begin giving injections. FDA clearance for Novavax’s vaccine was delayed for several weeks as the agency considered changes to the company’s manufacturing process.

Novavax was an early entrant in the US government’s race to develop a Covid vaccine in 2020, receiving $1.8 billion in taxpayer funding from Operation Warp Speed. However, the small Maryland biotech company struggled to get manufacturing up and running quickly, and its clinical trial data read much later than Pfizer or Moderna.

Novavax’s vaccines received FDA clearance at a time when nearly 77% of adults ages 18 and older are already fully immunized. However, 27 million adults have still not received a single vaccine. Dr. Peter Marks, a senior FDA official, said Novavax’s vaccine could potentially appeal to unvaccinated people who would prefer a vaccine that is not based on messenger RNA technology used by Pfizer and Moderna.

How Novavax is different

The Novavax vaccine is based on more conventional protein technology that has been used for decades in hepatitis B and HPV vaccines, while Pfizer and Moderna are the first FDA-approved vaccines to use mRNA.

Vaccines from Pfizer and Moderna use mRNA, a molecule encoded with genetic instructions, to tell human cells to produce copies of a viral particle called a spike protein. The immune system reacts to these copies of the spike, which prepares the human body to attack the actual virus.

Novavax makes copies of the virus spike outside of human cells. The spike’s genetic code is put into an insect virus that infects ringworm cells, which produce copies that are then purified and extracted during the manufacturing process. The finished spike copies are injected into the human body, inducing an immune response against Covid.

The Novavax vaccine also uses an additional ingredient called an adjuvant, which is extracted and purified from the bark of a tree in South America, to induce a broader immune response. The injections consist of 5 micrograms of the peak copy and 50 micrograms of the adjuvant.

Efficiency and safety

Two doses of the Novavax vaccine were 90% effective in preventing Covid disease across the board and 100% effective in preventing severe disease, according to clinical trial data in the United States and Mexico. However, the trial was conducted from December 2020 to September 2021, months before the omicron variant became mainstream.

Novavax presented no data on the vaccine’s efficacy against the variant at the FDA committee meeting in June. However, the vaccine will likely have less efficacy against omicron, as is the case with vaccines from Pfizer and Moderna. Omicron is so distinct from the original strain of Covid that antibodies produced by vaccines struggle to recognize and attack the variant.

Novavax released data in December showing that a third injection increased the immune response to levels comparable to the first two doses which were 90% effective against the disease. The company plans to ask the FDA to authorize a third dose of its vaccine.

The FDA clearance for Novavax’s vaccines comes as the United States prepares to update Covid vaccines to target the omicron BA.4 and BA.5 variants to increase protection against the virus. Novavax’s vaccine, like all other vaccines, is based on the original version of the virus that first appeared in Wuhan, China. The effectiveness of Covid vaccines against mild disease has declined significantly as the virus has evolved, although they still generally protect against severe disease.

Novavax presented data at an FDA committee meeting in late June showing that a third dose of its vaccine produced a strong immune response against omicron and its subvariants. Committee members were impressed with the company’s data on omicron.

The Novavax vaccine also appears to carry a risk of heart inflammation in younger men, known as myocarditis and pericarditis, similar to Pfizer and Moderna injections. Myocarditis is inflammation of the heart muscle and pericarditis is inflammation of the outer lining of the heart.

FDA officials reported four cases of myocarditis and pericarditis during the Novavax clinical trial in young men between the ages of 16 and 28. People who develop heart inflammation as a side effect of Covid vaccines are usually hospitalized for several days as a precaution, but then recover.

In the case of mRNA injections, the CDC found that the risk of myocarditis is higher from Covid infection than from vaccination. Myocarditis is usually caused by viral infections.

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