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First patients dosed with Moderna’s COVID-19 vaccine

More pharma players also join vaccine development efforts

Vaccine vial

The first person in the world to be injected with a COVID-19 vaccine – a 43-year-old mother from Seattle in the US – was dosed with Moderna’s candidate yesterday.

She was one of four people to be immunised yesterday with the mRNA-based vaccine, called mRNA-1273, in the study, which is being conducted by the US National Institutes of Health (NIH) at Kaiser Permanente Washington Health Research Institute in Seattle.

mRNA-1273 has reached the clinical testing stage in record time, just 63 days since the genetic code of the virus was identified by Chinese scientists and shared on 11 January, rather than the more usual months or years.

That’s because the urgency of the pandemic means Moderna has been given the green light to run some aspects of its development such as non-human primate challenge studies in parallel with human trials.

All told, the phase 1 trial aims to recruit 45 healthy men and women aged between 18 and 55 and will test two doses of the vaccine given 28 days apart, with 12 months’ follow-up after the second dose.

It will look at safety as well as how effectively mRNA-1273 can stimulate an immune response against COVID-19 proteins, but even if the trial goes well it still won’t be ready for large-scale access for around 18 months.

Approval for public use will need a larger phase 2 trial which is at the planning stage and could start within a few months, according to the US biotech.

At the moment it is producing batches of mRNA-1273 to dose to patients in that larger study, and is also scaling up production capacity to allow millions of doses to be made if it proves safe and effective.

Pfizer/BioNTech launch programme

Staying in the mRNA vaccine arena, Pfizer and German biotech BioNTech have signed a letter of intent to co-develop another potential mRNA coronavirus vaccine aimed at preventing COVID-19 infection – BNT162 – in all world markets outside China.

The two companies, who are already working together on an mRNA-based influenza vaccine under the terms of an agreement signed in 2018, say they could start clinical testing of BNT162 by the end of next month.

The letter of intent means that they can start collaborating on the COVID-19 vaccine straight away, and draw up financial and other terms later on.

EU backs CureVac with €80m funding package

Meanwhile, the European Commission has confirmed it has offered financial support of up to €80m to German biotech CureVac, shortly after the company was forced to deny allegations it had been offered $1bn to relocate to the US by the Trump administration so its COVID-19 candidate could preferentially benefit American citizens.

An EC statement said the cash injection was intended to help CureVac scale up development and production of its vaccine against new coronavirus in Europe, and would come from a European Investment Bank (EIB) loan guaranteed by the EU.

In what appears to be a nod to the Trump rumours, Commission President Ursula von der Leyen said: “I am proud that we have leading companies like CureVac in the EU. Their home is here. But their vaccines will benefit everyone, in Europe and beyond.”

Yesterday CureVac announced its chief executive Ingmarr Hoerr would take a leave of absence for medical reasons unrelated to COVID-19, with deputy Franz-Werner Haas taking the helm until his return.

Article by
Phil Taylor

17th March 2020

From: Research



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