Coronavirus: Moderna says early Covid-19 vaccine tests show ‘positive’ results
- Preliminary tests show mRNA 1273 vaccine candidate providing antibodies at levels seen in recovered Covid-19 patients
- Moderna expects to start a larger late-stage trial in July
Moderna Inc, the company developing a Covid-19 vaccine candidate supported by the US government, announced “positive interim clinical data” on Monday in preliminary human trials showing that the vaccine delivers antibodies at levels found in patients who have recovered from the disease.
Data from tests on eight subjects “elicited neutralising antibodies … as measured by plaque reduction neutralisation (PRNT) assays against live Sars-CoV-2”, the coronavirus that causes Covid-19, Moderna said about the early results of testing on its mRNA 1273 vaccine candidate. “The levels of neutralising antibodies at day 43 were at or above levels generally seen in convalescent sera”.
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Moderna, based in Cambridge, Massachusetts, also said that it saw dose-dependent increases in immunogenicity – the ability to provoke an immune response in the body – in all 45 participants in the study, who were given three different dosages, and that the vaccine has so far been “generally safe and well tolerated” by the test cohort.
There is currently no vaccine for the new coronavirus that emerged in China late last year, an outbreak that quickly spread to become a pandemic that has killed more than 300,000 people worldwide, though more than 100 vaccines are under development globally, according to the World Health Organisation. At least eight vaccines are in human trials.
Nor are there any formally approved treatments; the US Food and Drug Administration (FDA) earlier this month authorised the emergency use only of the experimental medication remdesivir, an antiviral produced by Gilead Sciences.
Health experts have warned that social distancing measures in place around the world to slow the Covid-19 spread will need to stay in place until an effective vaccine is available globally.
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The US government’s Biomedical Advanced Research and Development Authority (Barda), a division of the Department of Health and Human Services, provided US$483 million to fund development for Moderna’s vaccine candidate and plans to support its late-stage clinical development and manufacturing.
The FDA gave Moderna approval on May 6 to start phase-two trials on mRNA 1273 and announced last week that it had “fast-tracked” the vaccine candidate’s development.
“With today’s positive interim phase-one data and the positive data in the mouse challenge model, the Moderna team continues to focus on moving as fast as safely possible to start our pivotal phase-three study in July,” the company’s chief executive, Stéphane Bancel, said. “We are investing to scale up manufacturing so we can maximise the number of doses we can produce.”
Moderna’s stock price surged on Monday, following the company’s announcement. The Nasdaq-traded shares were up more than 20 per cent from Friday’s close.
On Friday, Moncef Slaoui, a former pharmaceutical executive named last week by US President Donald Trump to speed the development of a coronavirus vaccine, said he expected to accomplish the goal by the end of this year. Previously, US officials said producing a Covid-19 vaccine would take 12 to 18 months at the earliest.
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“I have very recently seen early data from a clinical trial with a coronavirus vaccine, and these data made me feel even more confident that we will be able to deliver a few hundred million doses of vaccine by the end of 2020,” Slaoui, a former head of vaccines for GlaxoSmithKline, said at a White House briefing, without disclosing which trial he was referring to.
Along with Barda funding, the government’s efforts to deliver a vaccine this year also relies on the US Defence Department, which is preparing to deliver syringes, vials and other equipment needed to administer the doses when cleared by the FDA. The logistics effort includes a “cold chain” to ensure that the vaccine stays at the needed temperature from the manufacturing plants to medical facilities.
Barda has earmarked funds for the scaling up of production at Moderna’s facilities and at Lonza, a Swiss company that is collaborating with the company.
