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modern announced the first results on Wednesday On an updated coronavirus vaccine targeting the Omicron variant, he calls it our “pioneer candidate” for the fall to serve as a US booster shot.

The firm’s researchers tested a booster dose that combined the original vaccine with a vaccine specifically targeting Omicron, the variant that became dominant last winter. They found that among those without evidence of previous coronavirus infection, the combination produced 1.75 times more neutralizing antibodies to Omicron than the current Moderna vaccine did alone.

While these results may seem encouraging on their faces, many experts worry that the virus has evolved so quickly that it has outstripped its ability to replace vaccines, at least as long as the United States relies on human clinical trials for results.

Moderna’s new findings from a clinical trial involving 814 volunteers show that the updated vaccine produced a significantly stronger immune response to Omicron than the current vaccine one month after the booster vaccine was given. The booster shots followed the three previous doses of Moderna’s vaccine.

But Omicron has been producing sub-variants for months, and some vaccine experts say what matters now is how well a new booster formulation will protect against the latest sub-variants BA.4 and BA.5, not Omicron itself. These two subvariables were first identified in South Africa earlier this year. now accounts for 13 percent of new cases in the United States, and it’s spreading fast. By some estimates, they could compete in a month two other Omicron sub-variants, BA.2 and BA.2.12.1currently dominant.

Moderna has not published any data on how the updated vaccine works against BA.4 or BA.5. In a presentation Wednesday morning, the firm’s president, Dr. Stephen Hoge said researchers are still collecting data on this and other subvariables.

But he said a very small sample, along with other isolated studies, suggest that neutralizing antibody levels triggered by the updated vaccine are two to three times lower against subvariants BA. But he said these levels are “still a very comfortable place”, a view echoed by at least one federal health official who reviewed the data.

Moderna officials said they cannot yet say whether the reconstituted vaccine will provide more lasting protection than the current vaccine, but are hopeful, based on earlier findings from a reconstituted vaccine study against a different variant released in April.

The newest sub-variants seem to be spreading faster than previous versions of Omicron and may be better at evading the immune system’s defenses. It is unclear whether they cause more severe disease. Chief medical adviser to the White House, Dr. Anthony S. Fauci said in an interview Tuesday: South Africa where BA.4 and BA.5 are common“It has seen a slight increase in hospitalizations, but ICU use and deaths remain really consistently low.”

In any case, given how quickly the virus mutates, some vaccine experts say it makes more sense to target the latest versions of the virus rather than the already passed or upcoming forms.

The problem is that Moderna and Pfizer, the makers of the other main coronavirus vaccine in the United States, still don’t have enough time to conduct more human clinical trials and produce a vaccine before the decline the Biden administration hopes to achieve. presenting an updated vaccine to predict a winter wave, according to what public health experts predict.

This could force regulators to choose updated vaccines based on data from laboratory testing and trials involving mice or other animals, rather than robust human trials. It’s also possible that another new variant or worrying sub-variant will emerge by the fall, further complicating the picture.

external consultants to the Food and Drug Administration, will meet on June 28 discussing which vaccine formulation will work best as a fall accelerator; There are vaccine manufacturers Said they should start production soon.

Dr. “Of course, the final decision is always left to the FDA,” said Fauci. “But what the FDA will probably do is keep as many irons on fire as possible. And they may need to go back to alternative decision paths that have lab data and possible animal data.”

When asked if Americans would accept a booster formulation without lengthy human trials, he said, “People who are really very concerned about protecting themselves will agree.”

John Moore, a virologist at Weill Cornell Medicine in New York, said that at this point in the pandemic, many healthcare professionals would be comfortable switching to a different model for coronavirus vaccine development, similar to the one used to replace the flu vaccine each year. Federal health officials said the composition of the annual flu vaccine has been modified to meet new variants with a minimum of new human testing.

Moderna’s vaccine trial targeting Omicron began in late February. The average age of the participants was 57 years. All volunteers received three shots—two shots—of Moderna’s current vaccine, followed by a booster dose an average of eight months after the second shot.

About four and a half months after this first booster, 377 volunteers received a second booster with the current vaccine, while 437 volunteers received the booster designed to work against Omicron. The updated booster produced a stronger immune response among both those who were previously infected and those who were not.

Overall, those who received the updated booster had 59 percent higher levels of neutralizing antibodies than those who received the current booster, according to data published by Moderna.

Antibodies are the body’s first line of defense in preventing coronavirus infection. Other immune responses that also defend against Covid-19 were not measured; performing these tests is much more complex and time consuming.

Moderna’s chief medical officer, Dr. Paul Burton described the results as quite encouraging. “We really feel that this is some kind of fundamental turning point in our fight against this virus – we can adapt to a variant,” he said.

However, Dr. Moore said that a less than two-fold increase in neutralizing antibodies over the current vaccine was “only a modest benefit.”

“Given the cost, logistics, and everything else involved, does this justify changing the vaccine composition?” He asked. “The discussion will be about that.”

German partners Pfizer and BioNTech are also testing an Omicron-specific vaccine and are expected to announce their results soon.

Moderna in April published preliminary results It’s on a reconstructed vaccine to attack the Beta variant, first detected in late 2020. The firm said this version of the vaccine triggered a stronger immune response than the first formulation, not only against Beta, but also against Delta and Omicron variants. . Moderna officials said they expected an Omicron-specific vaccine would be a better candidate, although they said the additional protection against Omicron lasted for six months.