Novavax’s Vaccine Works Well — Except on Variant First Found in South Africa

“This is really worrisome,” said Dr. Peter Hotez, a vaccine expert at the Baylor College of Medicine and the inventor of a coronavirus vaccine. “We have to have the American people vaccinated by late in the spring or early summer to have any hope in preventing the South African and the U.K. variants from taking over.”

Drug makers could update their vaccines and offer new shots at regular intervals, similar to the flu vaccine.

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Answers to Your Vaccine Questions

Currently more than 150 million people — almost half the population — are eligible to be vaccinated. But each state makes the final decision about who goes first. The nation’s 21 million health care workers and three million residents of long-term care facilities were the first to qualify. In mid-January, federal officials urged all states to open up eligibility to everyone 65 and older and to adults of any age with medical conditions that put them at high risk of becoming seriously ill or dying from Covid-19. Adults in the general population are at the back of the line. If federal and state health officials can clear up bottlenecks in vaccine distribution, everyone 16 and older will become eligible as early as this spring or early summer. The vaccine hasn’t been approved in children, although studies are underway. It may be months before a vaccine is available for anyone under the age of 16. Go to your state health website for up-to-date information on vaccination policies in your area

You should not have to pay anything out of pocket to get the vaccine, although you will be asked for insurance information. If you don’t have insurance, you should still be given the vaccine at no charge. Congress passed legislation this spring that bars insurers from applying any cost sharing, such as a co-payment or deductible. It layered on additional protections barring pharmacies, doctors and hospitals from billing patients, including those who are uninsured. Even so, health experts do worry that patients might stumble into loopholes that leave them vulnerable to surprise bills. This could happen to those who are charged a doctor visit fee along with their vaccine, or Americans who have certain types of health coverage that do not fall under the new rules. If you get your vaccine from a doctor’s office or urgent care clinic, talk to them about potential hidden charges. To be sure you won’t get a surprise bill, the best bet is to get your vaccine at a health department vaccination site or a local pharmacy once the shots become more widely available.

That is to be determined. It’s possible that Covid-19 vaccinations will become an annual event, just like the flu shot. Or it may be that the benefits of the vaccine last longer than a year. We have to wait to see how durable the protection from the vaccines is. To determine this, researchers are going to be tracking vaccinated people to look for “breakthrough cases” — those people who get sick with Covid-19 despite vaccination. That is a sign of weakening protection and will give researchers clues about how long the vaccine lasts. They will also be monitoring levels of antibodies and T cells in the blood of vaccinated people to determine whether and when a booster shot might be needed. It’s conceivable that people may need boosters every few months, once a year or only every few years. It’s just a matter of waiting for the data.

“This virus is throwing us curve balls every day, so I think we just need to be prepared for that and realize that the first generation of vaccines may need to be updated,” said Dr. Jesse L. Goodman, a professor of medicine and infectious diseases at Georgetown University.

Novavax’s trial in Britain tested how many volunteers developed symptoms of Covid-19 one week after receiving a second dose. The company said Thursday that its initial analysis showed that out of 62 participants who developed the illness, 56 had received a placebo and 6 had gotten the vaccine. The newer, more contagious variant first identified in Britain was found to have caused about 50 percent of the cases in the trial, Novavax said.

If those results were to bear out in the larger clinical trial in the United States and Mexico, which has enrolled about 16,000 out of a goal of 30,000 people, then it would put the vaccine on par with the Moderna and Pfizer-BioNTech vaccines, which were shown to be about 95 percent effective.

But the news in South Africa was not as encouraging. Novavax’s smaller trial found the vaccine to have a 49.4 percent efficacy overall. (The company reported that about 6 percent of the trial’s participants were positive for H.I.V., and for those who were not H.I.V. positive, the vaccine had a 60 percent efficacy.) The company said the trial began recording cases of Covid-19 from September through the middle of this month, when the more contagious variant was widely circulating. Novavax said 44 trial participants developed Covid-19, and it sequenced the genetic lineage of 27 cases. Of those, 25 cases were caused by the more contagious version of the virus.

The company also said that about one-third of the trial participants in South Africa had previously developed Covid-19 after being infected by the original form of the virus, and that their results showed those previous infections did not protect them against the new variant. The company said its vaccine did provide some protection for those who had previously contracted the disease, but did not include this group in its analysis.

source: nytimes.com