The Food and Drug Administration (FDA) and Novavax logos are seen on the back of a medical syringe and vials in this photo illustration.
Pavlo Gonchar | LightRocket | Getty Images
Food and Drug Administration has authorized novavaxTwo-dose vaccine for adults age 18 and older, fourth Covid shot to gain emergency approval in US Epidemic began.
The FDA’s decision comes weeks after its committee of independent vaccine expertsHeavy in favor of Novavax’s shot In early June, after an all-day public meeting in which they weighed data on the vaccine’s safety and its effectiveness in preventing disease from COVID.
The Centers for Disease Control and Prevention still needs to sign off on Novavax’s vaccine before pharmacies and other health care providers can start administering the shots. FDA authorization of Novavax vaccine delayed for weeks as agency reviews Changes in the manufacturing process of the company,
Novavax was one of the original participants 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 start manufacturing quickly and its clinical trial data were read much later than Pfizer or Moderna.
Shots of Novavax have received FDA authorization at a time when about 77% of adults age 18 and older have already been fully vaccinated. However, 27 million adults have yet to receive a single shot. A senior FDA official, Dr. Peter Marks, said Novavax’s vaccine would potentially appeal to people who have not been vaccinated who would prefer a shot that is not based on messenger RNA technology used by Pfizer and Moderna. .
How is Novavax Different?
The Novavax shot is based on the more traditional proteinase technology used for decades in the hepatitis B and HPV vaccines, while Pfizer and Moderna are the first FDA-approved vaccines to use mRNA.
The vaccines from Pfizer and Moderna use mRNA, a molecule encoded with genetic instructions, to tell human cells to make copies of a virus particle called a spike protein. The immune system reacts to these copies of the spike, preparing the human body to attack the actual virus.
Novavax makes copies of the virus spike outside human cells. The spike’s genetic code is then put into an insect virus that infects insect cells, producing copies that are purified and removed during the manufacturing process. The prepared spike copies are injected into the human body, triggering 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 broad immune response. Shots contain 5 µg of spike copy and 50 µg of adjuvant.
effectiveness and safety
According to data from clinical trials in the US and Mexico, two doses of the Novavax vaccine were 90% effective in preventing disease from COVID across the board and 100% in preventing severe disease. However, the trial was held from December 2020 to September 2021, months before the Omicron version went into effect.
Novavax presented no data on the shot’s effectiveness against the variant at an FDA committee meeting in June. However, the vaccine’s effectiveness against Omicron will be low, as is the case with shots from Pfizer and Moderna. Omicron is so different from the original strain of Covid that the antibodies produced by the vaccines have trouble recognizing and attacking the variant.
Novavax published data in December showing that a third shot boosted an immune response compared to the first two doses, with 90% effectiveness against the disease. The company plans to ask the FDA to authorize a third dose of its vaccine.
The FDA authorization of Novavax’s vaccines comes as the US prepares to update the COVID shots to target the Omicron BA.4 and BA.5 variants to enhance protection against the virus. Novavax’s vaccine, like all other shots, is based on the original version of the virus that first emerged in Wuhan, China. The effectiveness of COVID vaccines against mild disease has decreased substantially as the virus has evolved, although they still generally protect against severe disease.
Novavax submitted data FDA committee meeting in late June demonstrated that a third dose of its vaccine produced a strong immune response against Omicron and its subtypes. Committee members were impressed by the company’s figures on Omicron.
The Novavax vaccine also raises the risk of heart inflammation for young men, known as myocarditis and pericarditis, similar to shots from Pfizer and Moderna. Myocarditis is inflammation of the heart muscle and pericarditis is inflammation of the outer layer of the heart.
FDA officials flagged off four cases of myocarditis and pericarditis from a clinical trial of Novavax in young men aged 16 to 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 shotsThe CDC has found that the risk of myocarditis is greater with COVID infection than by vaccination. Myocarditis is usually caused by a viral infection.