San Francisco Chronicle - (Sunday)
New entry in vaccine field moves step closer
A fourth COVID-19 vaccine option could soon be available in the U.S., after Food and Drug Administration advisers recently recommended emergency use authorization for the shot made by Novavax.
The vaccine from the Maryland drugmaker is used overseas but is a latecomer to the U.S. field occupied for more than a year by Pfizer, Moderna and Johnson & Johnson — and it differs in several ways from those three now-familiar brands.
Art Reingold, a UC Berkeley epidemiologist and member of the FDA committee that gave Novavax the thumbs-up, provided insights about the vaccine to The Chronicle. Here are some of his comments, and other key details to know.
What is the Novavax vaccine and how does it work compared to the other COVID vaccines?
The COVID-19 vaccine made by Novavax is a two-dose regimen for people 18 and older that uses a more conventional protein-based approach than the three vaccines currently used in the U.S. , which deploy genetic material instructing host cells to make the coronavirus’ spike protein.
Two of the three approved versions, made by Pfizer and Moderna, are mRNA vaccines, which use messenger RNA to deliver instructions to cells to make a protein that triggers the production of antibodies that protect against coronavirus infection.
The third vaccine, made by Johnson & Johnson, is a viral vector vaccine that uses a harmless modified version of a different virus to trigger an immune response. The Novavax approach is an established technology, Reingold said. “There are a number of vaccines we routinely use that use more or less the same process,” he said. They include inoculations for hepatitis, shingles and the flu, among other illnesses and infections. Developed by Novavax and the Coalition for Epidemic Preparedness Innovations, the vaccine directly delivers purified pieces of the COVID-19 spike protein, which are unable to cause disease, combined with a substance called an adjuvant to help increase immune response.
Unlike the MRNA vaccines, which need to be stored at freezing temperatures, the Novavax vaccine can be stored at standard refrigeration temperatures.
What is its effectiveness?
Clinical trials in the U.S. and Mexico included about 30,000 adults, two-thirds of whom received the Novavax vaccine and one-third of whom received a placebo, Reingold said. The results showed 90.4% effectiveness at preventing symptomatic infection.
The trials took place before the omicron was circulating, however, so it’s unknown how well the vaccine protects against that highly infections variant and its subvariants that are now
Vials of freshly manufactured Novavax COVID-19 vaccines await labeling at a factory in Pune, India.
dominant across the world.
“The virus changes so quickly,” Reingold said. “It’s one of the limitations with the study … and the results, but the hope is that it will provide a reasonable level of protection against omicron if the FDA approves it.”
Where is the vaccine currently being used?
The Novavax vaccine, in development since early 2020, was first authorized for emergency use in Indonesia in November 2021. It has since been authorized in the Philippines, India, the European Union, South Korea, Australia, the United Kingdom, Canada and other countries. It has also been validated by the World Health Organization. A number of other protein-based COVID vaccines have been authorized around the world including in Taiwan, China and Russia.
Why has Novavax authorization taken so long in the U.S.?
With about threequarters of adults in the U.S. already inoculated
against COVID-19, Novavax has been outpaced by the larger, more experienced and wealthier Pfizer and Moderna, the Wall Street Journal reported. Novavax has grappled with manufacturing problems that hindered its rollout globally and pushed back the start of a large U.S. study, though CEO Stanley Erck has said those issues have been resolved.
Novavax submitted its request for FDA approval in January, but federal health officials have described the application as complex. The vaccine was created in the Novavax research lab, but it is produced by the Serum Institute of India and other factories, which also must satisfy FDA inspections, NBC reported.
The delays have elicited frustration from supporters on social media — sometimes called “Novastans” — eager for the traditional vaccine option, and from people with medical conditions that prevent them from using the currently approved versions.
Reingold attributed the lengthy U.S. approval process for Novavax to “extremely rigorous FDA requirements” to approve new vaccines and drugs, which he said are among the most cautious in the world. He said if U.S. regulators weren’t as careful and “rushing through the process,” people would be concerned and it could “risk safety.”
“We need to balance the urgency of a pandemic with the legitimate concern that the benefits outweigh the risks of anything we recommend to a large number of people,” he said.
What steps are left for U.S. approval?
Next, the full FDA will consider the panel’s recommendation and decide whether to grant emergency use authorization of Novavax — and likely will look at when and how booster doses might be administered, the Associated Press reported.
If that hurdle is cleared, the Centers for Disease Control’s Advisory Committee on Immunization Practices will weigh in, and finally, CDC Director Rochelle Walensky will need to sign off before the vaccine can be administered.
Western regional and California state health officials also typically weigh in, and have usually followed the CDC’s lead very quickly.
What side effects have been reported from Novavax?
The reported shortterm reactions after Novavax shots are similar to the other vaccines, including soreness at the injection site, fatigue, headache and muscle pain, which usually resolve within 12 to 24 hours, Reingold said. The FDA flagged a possible risk of developing inflammation of the heart after four instances of myocarditis, a rare heart condition also associated with mRNA vaccines, occurred in young men. However, the “overwhelming majority” of myocarditis cases after vaccination are “resolved completely,” Reingold said.
“It’s rare,” he said. “I would argue the benefits of vaccination still greatly outweigh that risk.”
What considerations would you keep in mind when picking which vaccine to use?
The mRNA vaccines are safe, Reingold said, and any concerns raised about their safety “are not supported by science.”
But he said the Novavax vaccine would be a good alternative to anyone who is unsure about the newer mRNA technology.
“Look carefully at getting this new vaccine if it’s approved,” he said. “We have used this technology before in other vaccines, and it is used in large numbers of people outside of the U.S.”
Reingold said he found the data presented to the FDA panel Tuesday“convincing,” and he would be “perfectly content to take that vaccine” and recommend it to his adult children.