Pfizer to seek FDA nod for third vaccine dose; shots still protect

Pfizer is about to seek the US authorisation for a third dose of its COVID-19 vaccine, saying 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 US infections. 

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Two doses of most vaccines are critical to developing 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.

But antibodies naturally wane over time, so studies also are 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 five- 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 authorisation of a third dose, he said.

Why might that matter for fighting the delta variant? Dolsten pointed to data from Britain and Israel showing the Pfizer vaccine “neutralises 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 authorisation 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.”

Currently, only about 48 percent of the US population is fully vaccinated — and some parts of the country have far lower immunisation rates, places where the delta variant is surging. On Thursday, Dr. Rochelle Walensky, Director of the Centers for Disease Control and Prevention, said that's leading to “two truths” — highly immunised swaths of America are getting back to normal while hospitalisations 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 US cases, but it now accounts for just over 50 percent — and in some places, such as parts of the Midwest, as much as 80 percent.

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 four-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 immunised before the virus evolves even more.

Researchers in Britain found two doses of the Pfizer vaccine, for example, are 96 percent protective against hospitalisation with the delta variant and 88 percent 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 percent.

Whether the fully vaccinated still need to wear masks in places where the delta variant is surging is a growing question. In the US, 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 cases.

“Let me emphasise, if you were vaccinated, you have a very high degree of protection,” Dr. Anthony Fauci, the US government's top infectious disease expert, said Thursday.

In the US, case rates have been rising for weeks and the rate of hospitalisations has started to tick up, rising 7 percent 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.