After ‘sobering’ data on vaccines, scientists are concerned: it will be difficult

The vaccines developed by Moderna Inc. and Pfizer Inc. in conjunction with their BioNTech SE partners are already in use. Meanwhile, new research suggests that two more vaccines developed by Johnson & Johnson (J&J) and Novavax against the primary forms of the virus could soon be approved for use: the J&J vaccine in the United States and Novavax in the United Kingdom.

But there is also bad news. Mutations believed to be partially resistant to vaccines and antibodies are now spreading in both South Africa and Brazil and threaten to spread throughout the world. In the United States, Johnson & Johnson’s single-dose vaccine for COVID-19 is 72% effective in phase III trials, but has dropped to 57% in studies in South Africa. Novavax is 89% efficient. In the UK, but in South Africa, the figure is only 49 percent.

Even before these results were published, laboratory tests for other vaccines led to the conclusion that these vaccines were likely to be less effective against the new strain of South African virus. But it is not clear what this means in terms of disease prevention in the real world. The new results clearly show that the vaccines will not be effective against at least one of the resulting mutations.

“Now we are faced with real world-class clinical consequences and we realize that challenges await us,” Anthony Fauci, a renowned expert on infectious diseases in the United States, said in a video conference.

Prior to the publication of the J&J and Novavax results, laboratory studies evaluating the levels of antibodies produced by Pfizer Inc. and Moderna Inc. vaccines that were already in use showed that, although these vaccines may be less potent in the South African strain, however, are effective enough to make the vaccine worthwhile.

But it is unclear what this means in terms of disease in the real world. Recent results suggest a more precise indication, America’s leading infectious disease expert Fauci said during a conference call.

“It really encourages us not to fall asleep, to concentrate and adapt quickly, because the virus will continue to develop and mutate,” he emphasized. “We now have real clinical results and we can anticipate the challenges.”

Speaking at the New York Press Club, Fauci said that “it is necessary to avoid these mutations and substantially crush this outbreak so that it does not happen again. And when there are no more replications, there will be no more mutations. “

However, both Pfizer, Moderna and J&J have emphasized that they are beginning to develop stronger doses and are looking for other ways to make their vaccines more effective. It is not clear how long the vaccines will immunize humans against COVID-19, and new mutations may require changes in their composition.

US application to states

The first step is to find out when mutations occur around you. During the meeting, Rochelle Walensky, director of the Centers for Disease Control and Prevention, said the United States is now asking each state to submit at least 750 samples a week to determine a certain sequence and find out which mutations are likely. to spread. He cautioned that the current US system for detecting different mutations is too slow to be controlled by public health interventions.

“When someone feels symptoms, they do a test, they get a positive result and we have a gene sequence, the ability to do real case control and a contact search is basically gone,” Walensky said. “We should treat each case as if it were a separate variant of this pandemic.”

Reaction “Paslanki”

Peter Marx, director of the US Food and Drug Administration (FDA) Biological Research and Evaluation Center, says the agency is working with industry to develop a definitive strategy to combat mutations. If the agency suspects that the virus is deviant enough and requires different detection methods, it will require small tests to make sure the vaccines are eliciting an immune response, he said.

According to Marx, the first studies may need to be done through an advisory committee, but the agency aims to simplify the process as much as possible and may require less data in the long run.

“We’re going to be pretty mobile in this place,” Marx said during a video seminar at the American Medical Association, “to get information on these varieties as quickly as possible, because they are obviously spreading so fast.”

Lab results

Both Pfizer and Moderna, the only manufacturers of two vaccines approved for use in the United States, have stated that their current vaccines should produce sufficient antibodies against the South African mutation and therefore not lose their efficacy.

The J&J vaccine may be another vaccine approved for use in the United States. The pharmaceutical giant plans to submit an application to the Food and Drug Administration (FDA) for authorization for emergency use. A senior scientist at the company said in January that he expected permission to be granted in March.

Meanwhile, Novavax vaccines are likely to be approved for the first time for use in the UK; Additionally, the company is discussing with US regulators whether clinical trial data from other countries could be used to evaluate the vaccine, said Stan Erck, Novavax CEO.

The company is still engaging patients in clinical trials in the United States and Mexico, Erck said in an interview with Bloomberg Television.

Rapid propagation

The South African strain, or B.1.351, has already spread rapidly on the African continent and is found in at least 24 countries outside of Africa. This week two cases were identified in the United States, in South Carolina. Meanwhile, a highly contagious strain from the UK, first detected in the United States on December 29, has spread to 29 states in less than a month, and US health officials are warning that this altered virus could quickly become dominant.

While every country in the world is trying to curb the spread of varieties by imposing travel restrictions, history shows that this mission is nearly impossible.

The results of the South African clinical research are “sober,” says Eric Topol, director of the Scripps Translational Research Institute in San Diego. “We are definitely seeing less efficiency.”

According to Topolis, this means that the world should now focus its efforts on developing a new modified vaccine or a maintenance (booster) injection that would have a stronger effect on the South African strain, although it is still trying to speed up vaccination with the South African strain. . first vaccines.

“We are still struggling to implement the first phase of vaccination,” he said.

Long fight

The main message sent by the scientists is that this is a fight that can last a long time. Vaccines that work well now may become less effective in the future unless booster doses are created that vaccine manufacturers are already starting to work on. And it is possible that COVID-19 will change to some other form of flu-like infection that will require so-called periodic maintenance injections over many years to control it.

“These findings are really concerning,” said Peter Hotez, dean of the National School of Tropical Medicine at Baylor Medical College, in an interview following the announcement of the Novavax results. “All vaccine manufacturers now have to decide how to proceed,” he said.

Drug makers could start work on a new vaccine called bivalent, a two-component combination vaccine that would boost the immune system against both the primary strain and the South African strain, Hotez said. Or, he said, they could keep their current vaccines and adapt groundbreaking vaccines to generate antibodies that would neutralize the new strains.

Emergency vaccination

All three vaccine makers, Pfizer, Moderna and J&J, say they are developing destructive injections or other measures against the South African strain. Meanwhile, efforts are being made to speed up the vaccination process in the United States and Europe, before the strains from South Africa and Brazil become widespread or, worse, before new mutations appear that make the virus more resistant.

Mr. Fauci said in a statement to the New York Press Club that he was not allowed to fall asleep at night with the idea of ​​a “mutant who would really resist anyone.”

According to him, “It is worrying that these mutants desperately need to be avoided and that the outbreak must be substantially eradicated so that there are no further recurrences. And if there are no more repeats, there will be no mutations. “

Researchers at Columbia University’s Aaron Diamond AIDS Research Center have reported that the Pfizer and Moderna vaccines are 6.5 to 8.6 times less potent against the South African mutation.

“Looking at our results, you can’t say that the vaccine is doomed. That would be wrong. But in my opinion, it would be just as wrong to say that everything is covered in roses,” said virologist David Ho, who runs the lab. – We have already allowed the virus to infect 100 million people, so there are 100 million potential for mutation. “