Covid-19 roundup: Pfizer/BioNTech shot just as effective in real world, study says, as pair preps variant booster shots
The first real-world evidence for Pfizer/BioNTech’s Covid-19 vaccine is in, and there’s a lot for the companies to like.
Two months into the vaccine’s rollout in Israel, researchers from the country’s Clalit Research Institute have published the first study to be peer-reviewed over whether or not the shot is effective outside a controlled clinical trial setting. They have found the two-dose vaccine regimen cut symptomatic Covid-19 cases by 94% across all age groups and severe cases by almost as much.
Those figures almost exactly match up with Pfizer’s Phase III study for the shot, which showed a 95% efficacy rate. Full results were published Wednesday in the New England Journal of Medicine.
The study of nearly 1.2 million people also showed a single shot was 57% effective in protecting against symptomatic infections after two weeks.
Researchers told Reuters that they expected the figures in the real-world study to be lower than the clinical trial numbers, largely due to the fact that it’s more difficult to maintain cold storage capabilities outside of controlled settings. But they ended up getting similar figures regardless, which surprised senior author Ran Balicer.
“We have shown the vaccine to be as effective in very different sub-groups, in the young and in the old, in those with no comorbidities and in those with few comorbidities,” he told Reuters.
The study appeared to suggest that the Pfizer/BioNTech shot is also effective at protecting against the coronavirus variant that first appeared in the UK, which was the dominant strain in Israel at the time of the study. Researchers couldn’t pin down an exact level of efficacy, however, and there was no information about how effective the shots are against the South Africa virus variant.
Israel says more than half of its population of 9 million have received at least one shot, and a third have received both doses since rollout started last Dec. 19. The study examined a group of 600,000 vaccinated individuals versus about the same number of unvaccinated people as a control.
Wednesday’s news also comes amid growing international criticism that Israel has not done enough to vaccinate the Palestinian population living in the territories under which it asserts sovereignty. Prime Minister Benjamin Netanyahu acknowledged for the first time on Wednesday that Israel has been sharing some of its Covid-19 vaccines with countries that have given favors to Israel in the past, according to an Associated Press report.
Pfizer/BioNTech prep trials for booster and variant-based shots
As coronavirus variants continue to trigger concerns worldwide, Pfizer and BioNTech are preparing a new trial to potentially counteract their spread.
The companies will launch a study involving participants from their Phase I trial to evaluate the safety and efficacy of a third shot, they announced Thursday morning. Individuals who received their two shots 6 to 12 months ago will be offered a 30µg booster of the current vaccine.
“While we have not seen any evidence that the circulating variants result in a loss of protection provided by our vaccine, we are taking multiple steps to act decisively and be ready in case a strain becomes resistant to the protection afforded by the vaccine,” Pfizer CEO Albert Bourla said in a statement.
Up to 144 volunteers from the original Phase I study will be recruited from two age cohorts — those aged 18-55 and those between 65 and 85 years old. The companies said the study will measure the safety and tolerability of a third vaccination irrespective of the level of antibody titers of the trial participant.
Researchers will assess participants at the time they receive the dose, one week later and one month later. Pfizer and BioNTech then plan to study the ability of the serum from those participants to neutralize strains of interest.
The pair are also talking with regulatory bodies to plan an additional pivotal trial for a variant-based vaccine based on the mutation first discovered in South Africa. They say they are following established regulatory pathways similar to what is used for flu vaccines.
AstraZeneca, EU tension flares again
The tit-for-tat between AstraZeneca and the European Union continued Thursday, as concerns among EU officials linger over whether the British drugmaker can come through on its Covid-19 vaccine supply promises.
AstraZeneca is aiming to deliver 180 million doses in the second quarter, including 20 million shots to Italy, the head of the company’s Italian unit told an Italian newspaper Thursday, according to Reuters. But per a separate Reuters report earlier this week, that number still falls well short of what the continent was promised.
An EU official on Tuesday said the company would miss its supply target by half, prompting some ugly comparisons from politicians.
“AstraZeneca is behaving like an unreliable second-hand car salesman. Getting reliable data from this company is still a challenge,” said EU lawmaker Esther de Lange, VP of the largest party in the bloc’s parliament.
The company’s contract had called for 300 million shots to be delivered by the end of June, but CEO Pascal Soriot has said the contracts are not legally binding due to a “best effort” clause in the text.
EU officials had been skeptical of that claim, but after the bloc published the contract in an effort to boost transparency earlier this month and mistakenly left some portions unredacted, eagle-eyed internet sleuths and German journalists discovered text appearing to back Soriot’s assertion. The mistake prompted the EU to publicly apologize.
Thursday is just the latest round in an ongoing spat between the bloc and the vaccine maker. Things started heating up late last month when AstraZeneca notified the bloc that it would deliver roughly 60% fewer doses than originally promised, blaming production problems at a Belgian factory. That triggered fiery backlash from the EU, which was already dealing with delays of the Pfizer/BioNTech vaccine and lags in vaccination.
The news also comes as reports emerge of European individuals, as well as health care workers, refusing to take the AstraZeneca vaccine at all. Bloomberg reported last week that frontline health workers in Germany and France are pushing to get shots from Moderna and Pfizer/BioNTech.
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