COVID-19 Vaccine Sprint As Pfizer-BioNTech And Moderna Seek Emergency EU Approval

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FRANKFURT (Reuters) – Moderna and Pfizer-BioNTech are in a close race to launch their COVID-19 vaccines in Europe after both seeking emergency EU approval on Tuesday, although there was uncertainty as to whether a deployment could begin this year.

The requests to the European Medicines Agency (EMA) came a day after Moderna requested emergency use for its injection in the United States and more than a week after Pfizer and BioNTech followed suit.

US pharmaceutical maker Pfizer and its German development partner BioNTech have said their vaccine could be launched in the European Union as early as this month.

“We can start delivering within hours (after approval),” said Sierk Poetting, operations and finance manager at BioNTech. “We get our supplies. And whatever is there can really be distributed within hours.

However, the EMA clouded the timeline when it announced it would complete its review for this vaccine by December 29 and Moderna’s vaccine by January 12. She added that her schedule may be subject to change as she is assessed.

The European Commission, the EU’s executive body, has said it will likely give its final clearance for a vaccine deployment days after a recommendation from the EMA.

Effective vaccination is considered the main weapon against the pandemic, which has claimed more than 1.4 million lives and devastated economies around the world. Around 50 potential vaccines are currently being tested on volunteers around the world.

FILE PHOTO: The Biontech logo is visible through a 3D printed Pfizer logo in this illustration taken November 10, 2020. REUTERS / Dado Ruvic / File Photo

US biotech company Moderna and Pfizer-BioNTech have reported preliminary results of over 90% efficacy – a surprisingly high rate – in trials of their vaccines, both based on new messenger RNA (mRNA) technology .

PERSONALIZED GENETIC CODE

Their work validates that of several biotechnology experts, who for years have struggled to prove a once unorthodox idea: the human body can act as its own vaccine factory.

Both inoculations work by injecting people with a personalized genetic code that instructs human cells to make key viral proteins to induce an immune response.

Pfizer and BioNTech reported final test results on Nov. 18 that showed their vaccine candidate, known as BNT162b2, to be 95% effective in preventing COVID-19, without major safety concerns.

Moderna Inc said on Monday that the full results of an advanced stage study showed its candidate, mRNA-1273, to be 94.1% effective, also without serious safety concerns.

Any authorization in the EU and US for vaccines will be “conditional” or for “emergency use”, meaning developers are obligated to continue testing and provide more test results to as they emerge.

The European filings complement the so-called continuous reviews, initiated by the EMA on October 6 in the case of Pfizer and November 16 for Moderna, aimed at speeding up the process by performing a real-time assessment of the data as it becomes arrive. .

The EMA said on Tuesday it had started an ongoing review of Johnson & Johnson’s vaccine candidate after preliminary results showed it triggers the production of antibodies and immune cells against the virus. The review will continue until sufficient evidence is available for a formal marketing authorization application, the regulator added.

The UK government said here last week that Pfizer and BioNTech had reported their clinical trial data to the Medicines and Health Products Regulatory Agency (MHRA).

Reporting by Ludwig Burger and Josephine Mason; Additional reporting by Markus Wacket in Berlin; Editing by Pravin Char

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