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US vaccine approval draws near

Thursday November 19th 2020

Developers of the first COVID-19 vaccine will be seeking formal approval for use in the USA "within days", it has been announced.

Pfizer released the second tranche of clinical findings from its trial of the mRNA vaccine, claiming 95% efficacy.

It said that efficacy in people over the age of 65 was 94%.

More than 43,000 people have been involved in the randomised trial of the vaccine. Within 28 days of receiving the first dose, 162 cases of infection were detected in those receiving a placebo compared with eight amongst those who were vaccinated.

The company reports that no serious safety concerns have been found. Ten participants developed severe disease – one of them after being vaccinated. The other nine had received the placebo vaccine.

Pfizer said it was ready to deploy 50 million doses of the vaccine this year, using specially designed dry ice packaging to maintain its low temperatures during movement.

It plans to seek approval for emergency use from the US Food and Drug Administration “within days,” stating that the US required safety milestones have been achieved.

Dr Ugur Sahin, founder of BioNTech, the German company that devised the vaccine, said: “These achievements highlight the potential of mRNA as a new drug class. Our objective from the very beginning was to design and develop a vaccine that would generate rapid and potent protection against COVID-19 with a benign tolerability profile across all ages.

“We believe we have achieved this with our vaccine candidate BNT162b2 in all age groups studied so far and look forward to sharing further details with the regulatory authorities.”

* Oxford University researchers have published promising findings from a phase 2 trial of a new Ebola vaccine.

The replication-deficient adenovirus vaccine promotes a strong immune system response after two doses, delivered up to 84 days apart, according to a report in Lancet: Infectious Diseases.

According to the study, high levels of antibodies persist for at least a year after vaccination with the Janssen developed virus.

Researcher Professor Andrew Pollard said: “This is the second Ebola vaccine to be licensed, which means we are now better prepared for future outbreaks of this horrific disease and will be able to pre-emptively vaccinate those who are in the front line.”

Lancet: Infectious Diseases 17 November 2020

[abstract]

Tags: Flu & Viruses | North America | Pharmaceuticals | UK News

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