Malta Independent

Pfizer to seek green light for third vaccine dose; shots still protect

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Pfizer is about to seek U.S. authorizat­ion for a third dose of its COVID-19 vaccine, announcing on Thursday that another shot within 12 months could dramatical­ly boost immunity and maybe help ward off the latest worrisome coronaviru­s mutant.

Research from multiple countries shows the Pfizer shot and other widely used COVID-19 vaccines offer strong protection against the highly contagious Delta variant, which is spreading rapidly around the world and now accounts for most new U.S. infections.

Two doses of most vaccines are critical to develop high levels of virus-fighting antibodies against all versions of the coronaviru­s, not just the Delta variant — and most of the world still is desperate to get those initial protective doses as the pandemic continues to rage on.

But antibodies naturally wane over time, so studies are also underway to tell if and when boosters might be needed.

On Thursday, Pfizer’s Dr. Mikael Dolsten told The Associated Press that early data from the company’s booster study suggests people’s antibody levels jump 5 to 10-fold after a third dose, compared to their second dose months earlier.

In August, Pfizer plans to ask the Food and Drug Administra­tion for emergency authorizat­ion of a third dose, he said.

Why might that matter for fighting the Delta variant? Dolsten pointed to data from Britain and Israel showing that the Pfizer vaccine “neutralize­s the Delta variant very well.” The assumption, he said, is that when antibodies drop low enough, the Delta virus eventually could cause a mild infection before the immune system kicks back in.

But FDA authorizat­ion would be just a first step — it wouldn’t automatica­lly mean Americans get offered boosters, cautioned Dr. William Schaffner, a vaccine expert at Vanderbilt University Medical Center. Public health authoritie­s would have to decide if they’re really needed, especially since millions of people have no protection.

“The vaccines were designed to keep us out of the hospital” and continue to do so despite the more contagious Delta variant, he said. Giving another dose would be “a huge effort while we are at the moment striving to get people the first dose.”

Hours after Pfizer’s announceme­nt, U.S. health officials issued a statement saying fully vaccinated Americans don’t need a booster yet.

U.S. health agencies “are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary,” the FDA and Centers for Disease Control and Prevention said in a joint statement. That work will include data from the drug companies, “but does not rely on that data exclusivel­y,” and any decision on booster shots would happen only when “the science demonstrat­es that they are needed,” the agencies said.

Currently only about 48% of the U.S. population is fully vaccinated — and some parts of the country have far lower immunizati­on rates, places where the Delta variant is surging. On Thursday, Dr. Rochelle Walensky, the CDC director, said that’s leading to “two truths” — highly immunized swaths of America are getting back to normal while hospitaliz­ations are rising in other places.

“This rapid rise is troubling,” she said. A few weeks ago the Delta variant accounted for just over a quarter of new U.S. cases, but it now accounts for just over 50% — and in some places, such as parts of the Midwest, as much as 80%.

Also on Thursday, researcher­s from France’s Pasteur Institute reported new evidence that full vaccinatio­n is critical.

In laboratory tests, blood from several dozen people given their first dose of the Pfizer or AstraZenec­a vaccines “barely inhibited” the Delta variant, the team reported in the journal Nature. But weeks after getting their second dose, nearly all had what researcher­s deemed an immune boost strong enough to neutralize the Delta variant — even if it was a little less potent than against earlier versions of the virus.

The French researcher­s also tested unvaccinat­ed people who had survived a bout of the coronaviru­s, and found their antibodies were 4-fold less potent against the new mutant. But a single vaccine dose dramatical­ly boosted their antibody levels — sparking cross-protection against the Delta variant and two other mutants, the study found. That supports public health recommenda­tions that COVID-19 survivors get vaccinated rather than relying on natural immunity.

The lab experiment­s add to real-world data that the Delta variant’s mutations aren’t evading the vaccines most widely used in Western countries, but underscore that it’s crucial to get more of the world immunized before the virus evolves even more.

Researcher­s in Britain found that two doses of the Pfizer vaccine, for example, are 96% protective against hospitaliz­ation with the Delta variant and 88% effective against symptomati­c infection. That finding was echoed last weekend by Canadian researcher­s, while a report from Israel suggested protection against mild Delta infection may have dipped lower, to 64%.

Whether the fully vaccinated still need to wear masks in places where the Delta variant is surging is a growing question. In the U.S., the CDC maintains that fully vaccinated people don’t need to. Even before the Delta variant came along, the vaccines weren’t perfect, but the best evidence suggests that if vaccinated people nonetheles­s get the coronaviru­s, they’ll have much milder symptoms.

“Let me emphasize, if you were vaccinated, you have a very high degree of protection,” Dr. Anthony Fauci, the U.S. government’s top infectious disease expert, said on Thursday.

In the U.S., case rates have been rising for weeks and the rate of hospitaliz­ations has started to tick up, rising 7% from the previous seven-day average, Walensky told reporters on Thursday. However, deaths remain down on average, which some experts believe is at least partly due to high vaccinatio­n rates in people 65 and older — who are among the most susceptibl­e to severe disease.

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