Pfizer Vaccine Effective Against Variants – Moderna Booster Shows Promise 
Healthcare workers vaccinating at risk patients with the Pfizer-BioNTech COVID-19 vaccine in Lima, Peru.

Pfizer on Friday became the first pharma company to apply for full approval of its COVID-19 vaccine from the US Food and Drug Administration (FDA. The announcement also followed the publication of two studies which found that the Pfizer/BioNTech vaccine is highly effective against two major SARS-CoV2 variants of concern. Moderna plans to follow suit and apply for full approval from the FDA later this month, the company announced on Thursday.

Two peer reviewed studies published on Wednesday found that the Pfizer/BioNTech COVID-19 vaccine protects against severe disease caused by the B.1.1.7 variant, first identified in Britain, and the B.1.351 variant, first identified in South Africa. The studies were based on the real-world use of the vaccine in Qatar and Israel.

The Qatar-based study, published in the New England Journal of Medicine, used data on vaccinations, PCR tests, and hospitalization from the national COVID-19 databases between February and March.

Some 385,853 people received one dose since the launch of the immunization campaign and 265,410 people received both doses of the vaccine, as of the end of March. 

Efficacy of the vaccine in preventing infection was estimated to be 87% against the B.1.1.7 variant and 72.1% against the B.1.351 variant two weeks past the second dose. Protection was even higher against severe or fatal disease, with a total efficacy of 97.4%.

A second study based on Israeli data, and published in the Lancet, found that two doses of the Pfizer vaccine was highly effective against a range of SARS-CoV2 outcomes, including symptomatic (97%) and asymptomatic infection (91.5%), hospitalization (97.2%), and death (96.7%), in those aged 16 and older.

The B.1.1.7 variant was the dominant strain of SARS-CoV2 in the study period, from January to April. The variant accounted for 94.5% of the infections recorded by national surveillance data. 

As vaccine coverage increased in the study participants, the incidents of SARS-CoV2 outcomes declined. Other countries could “similarly achieve marked and sustained declines in SARS-CoV2 incidence if they can achieve high vaccine uptake” said the co-authors, from Pfizer and the Israeli Public Health Services.  

Israel has vaccinated a larger proportion of its population than any other country, with 61% of the population having received at least one jab as of early April. 

Positive Early Findings from Moderna Booster Shot Study

A doctor preparing the Moderna COVID-19 vaccine at the Naval Hospital in Bremerton, Washington, US.

In other vaccine news, Moderna announced on Thursday that initial data on its COVID-19 booster shots demonstrated that the boosters increased the neutralizing antibody responses of vaccinated individuals against two variants of concern.

The data is from an ongoing phase 2 study in which three strategies for boosting immune responses are being tested: a booster dose of Moderna’s existing vaccine, a booster candidate based on the B.1.351 variant, and a booster candidate that combines the two previous boosters.

After six to eight months following the administration of the second jab, the level of antibodies against the wild-type SARS-CoV2 remained high in the study participants, but antibodies against the B.1.351 and P.1 variants, first identified in Brazil, were much lower. 

“We are encouraged by these new data, which reinforce our confidence that our booster strategy should be protective against these newly detected variants,” said Stéphane Bancel, CEO of Moderna, in a press release.

While the findings are encouraging, the data has not yet been peer reviewed. According to the pharma company, the preliminary results have been submitted as a preprint and will later be submitted for peer-reviewed publication upon the completion of another arm of the study. 

Pfizer License Application 

The Biologics License Application (BLA) was initiated for the approval of the vaccine in individuals 16 years of age and above. Data will be submitted to the regulatory agency on a rolling basis and the review process will likely take several months.

“Following the successful delivery of more than 170 million doses to the US population in just a few months, the BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future,” said Ugur Sahin, CEO of BioNTech, Pfizer’s German manufacturer,  in a press release

Some 134 million doses of the Pfizer/BioNTech vaccine have been administered in the US, as of Thursday, according to the US Centers for Disease Control and Prevention (CDC).

The FDA is expected to issue emergency use authorization for the Pfizer vaccine in adolescents aged 12 to 15 early next week. 

Image Credits: BioNTech, International Monetary Fund/Ernesto Benavides, Flickr – Official US Navy.

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