Novavax, a little-known company supported by the US federal government’s Operation Warp Speed, said for the first time on Thursday that its Covid-19 vaccine offers robust protection against the virus. But he also found that the vaccine is not as effective against the rapidly spreading variant first discovered in South Africa, another setback in the global race to end a pandemic that has already killed more than 2.1 million people.
The news was problematic for the United States, which hours earlier reported its first known cases of the contagious variant in two unrelated people in South Carolina. And it came just days after Moderna and Pfizer said their vaccines were also less effective against same variant.
Novavax, which makes one of six vaccine candidates supported by Operation Warp Speed last summer, has been testing in Britain, South Africa, the United States and Mexico. He said on Thursday that an initial analysis of his test of 15,000 people in Britain revealed that the two-dose vaccine had an effectiveness rate of almost 90% there. But in a small trial in South Africa, the effectiveness rate dropped to just under 50%. Almost all the cases that scientists have analyzed so far have been caused by the variant, known as B.1.351. The data also showed that many trial participants were infected with the variant, even after they already had Covid.
“We have the first test – we are the first to conduct an effectiveness test – in the face of a virus change,” said Stanley Erck, president and chief executive of Novavax. He said the researchers hoped that the variants could alter the test results, but “the amount of changes was a surprise to everyone.”
The South African trial was relatively small – with only 4,400 volunteers – and was not designed to provide an accurate estimate of how much protection the vaccine offers. Still, the results were surprising enough that the company said it would soon start testing a new vaccine tailored to protect against the South African variant. “You will have to make new vaccines,” said Erck.
While the Pfizer and Moderna vaccines rely on a new mRNA technology that was not used in previous vaccines, Novavax’s candidate employs an older and more established method that relies on the injection of coronavirus proteins to elicit an immune response.
The fact that three vaccines appeared to show reduced efficacy against the South African variant is not encouraging, and the results that Novavax announced on Thursday were the first to occur outside a laboratory, testing how well a vaccine worked in people infected with a new variant. Johnson & Johnson is also about to announce the results of its Covid-19 vaccine tests and has also tested its candidate in South Africa.
Novavax’s announcement raises the stakes for Johnson & Johnson. The company was expected to announce its results as early as last weekend, and the delay has sparked speculation among scientists that the company also found that its vaccine worked less well in South African trial volunteers infected with the variant. In a earnings conference call on Tuesday, Alex Gorsky, the company’s CEO, said he was looking forward to sharing the results of his last test stage early next week.
The emergence of several highly contagious variants has complicated efforts to bring the pandemic under control, prompting world leaders to halt travel to places like Britain and South Africa, even though the variants already appear to have circled the globe. In the United States, researchers have warned that the variant first identified in Britain, which is believed to be the most infectious, could become the dominant form of the virus in this country in March.
The United States is far behind other countries in testing such variants, and that of South Africa has been found in about 30 countries.
But experts also said there are reasons for optimism, noting that vaccines remain effective. The best way to combat new contagious variants is to continue vaccination and other public health measures, which will decrease the virus’s ability to infect new people and suffer more mutations. Drug manufacturers can update their vaccines and offer new injections at regular intervals, similar to the flu vaccine.
Vaccines for covid19>
Answers to your vaccine questions
Currently, more than 150 million people – almost half the population – can be vaccinated. But each state makes the final decision about who goes first. The country’s 21 million health workers and three million residents in long-term care facilities were the first to qualify. In mid-January, federal authorities urged all states to open eligibility for everyone aged 65 and over and 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 rear of the line. If federal and state health officials can resolve bottlenecks in vaccine distribution, everyone aged 16 and over will be eligible as early as this spring or early summer. The vaccine has not been approved in children, although studies are ongoing. It may take months before a vaccine is available to anyone under the age of 16. Go to your state’s health website for up-to-date information on vaccination policies in your area
You should not have to pay anything out of your pocket to get the vaccine, although insurance information is requested. Even if you do not have insurance, you should receive the vaccine free of charge. Congress passed legislation this spring that prohibits insurers from applying any cost sharing, such as copayment or deductibles. He imposed additional protections, preventing pharmacies, doctors and hospitals from charging patients, including those without insurance. Even so, health experts fear that patients may run into loopholes that leave them vulnerable to unexpected bills. This can happen for those who pay a medical consultation fee with their vaccine, or Americans who have certain types of health coverage that do not fall under the new rules. If you get the vaccine at a doctor’s office or urgent care clinic, talk to them about possible hidden costs. To make sure you don’t get a surprise bill, the best bet is to get your vaccine at a vaccination post in the health department or at a local pharmacy as soon as the vaccines are more widely available.
This must be determined. It is possible that Covid-19 vaccines will become an annual event, as well as the flu vaccine. Or it may be that the benefits of the vaccine last for more than a year. We have to wait and see how durable vaccine protection is. To determine this, the researchers will screen vaccinated people for “innovative cases” – those who fall ill with Covid-19 despite the vaccination. This is a sign of weakened protection and will give researchers clues as to how long the vaccine lasts. They will also monitor the levels of antibodies and T cells in the blood of vaccinated people to determine whether and when a booster injection may be needed. It is conceivable that people need reinforcements every few months, once a year or just every few years. It is just a matter of waiting for the data.
The Novavax trial in Britain tested how many volunteers developed symptoms of Covid-19 a week after receiving a second dose. The company said on Thursday that its initial analysis showed that of the 62 participants who developed the disease, 56 received a placebo and 6 received the vaccine. The newest and most contagious variant first identified in Britain caused about 50 percent of the cases in the trial, Novavax said.
If these results were confirmed in the largest clinical trial in the United States and Mexico, which enrolled about 16,000 of a target of 30,000 people, this would put the vaccine on a par with the Moderna and Pfizer-BioNTech vaccines, which showed to be around 95% effective.
But the news in South Africa was not so encouraging. The smaller Novavax trial found that the vaccine had an overall effectiveness of 49.4%. (The company reported that about 6 percent of trial participants were HIV positive, and for those who were not HIV positive, the vaccine was 60 percent effective.) The company said the trial started recording cases of Covid- September 19 to the middle of this month, when the most contagious variant was widely circulating. Novavax said 44 study participants developed Covid-19, and it sequenced the genetic lineage of 27 cases. Of these, 25 cases were caused by the most contagious version of the virus.
The company also said that about a third of study participants in South Africa had developed Covid-19 before being infected with the original form of the virus, and that their results showed that these previous infections did not protect them against the new variant. The company said that its vaccine offers some protection for those who have already contracted the disease, but did not include this group in its analysis.
Novavax started working on a new version of the vaccine this month to deal with more contagious variants, which could serve as a booster injection or which could be administered at the same time as the original vaccine.
Variant B.1.351 first caught the attention of scientists in December. It contains several mutations, including some that change the shape of the virus’s surface and weaken the effectiveness of vaccines.
Looking at the oldest samples, South African scientists found the first evidence of B.1.351 dating from October. But by December, it had spread across the country, becoming the dominant strain of the coronavirus in many regions.
This alone would make B.1.351 a worrying development. In Britain, researchers found another fast-spreading variant known as B.1.1.7. In Brazil and California, other scientists have found variants that may be more contagious than previous forms of the coronavirus.