Coronavirus: two US drug companies close in on vaccine

Moderna is entering late-stage trials amid promising results from potential Covid-19 vaccine tests

A nurse prepares a shot of the possible vaccine. AP

Two American pioneers in the battle to produce a Covid-19 vaccine have announced progress, with drug firm Moderna revealing on Wednesday that it was taking the risk of stockpiling its candidate in anticipation of regulatory approval.

In a webcast to announce the company's second-quarter results of $3.1 billion (Dh11.38bn), the US biotechnology firm's chief executive, Stephane Bancel, confirmed that Moderna was on track to supply 500 million doses a year from 2021.

Mr Bancel said that as Moderna pivoted to a “commercial stage” it would price any approved product in a way that would make it widely accessible during the pandemic.

He said that discussions over supply agreements had begun with the governments of several countries, with Moderna already having received about $400 million of customer deposits for a potential supply.

“We will not share our inventory numbers at this time but I can tell you that as we speak our teams are making commercial products assuming the potential approval of mRNA1273,” Mr Bancel said. “So we are literally making products and stockpiling at risk.

“In terms of capacity, I’ll confirm what we have said before, which is for 2021 the 500 million doses per year continues to be our base plan.”

An early trial of Moderna’s pioneering messenger RNA vaccine resulted in all 45 patients producing a robust antibody response. When the news was made public a few weeks ago the company’s stock rose more than 16 per cent in after-hours trading.

The Moderna vaccine is one of the few to proceed to the final stages of testing. The company began a phase 3 trial on July 27 with enrolment of 30,000 volunteers in the US to be completed next month. The late-stage trial will aim to demonstrate that the potential vaccine is safe and effective, the final hurdle prior to regulatory approval.

September is also the intended date for the US company Novavax to begin a large, phase 3 trial. Novavax announced on Tuesday that the company’s experimental vaccine produced high levels of antibodies against Covid-19 in its promising early-stage clinical trial.

A substance designed by the company to bolster the body’s immune response was also shown to enhance the effect of the vaccine.

The Novavax vaccine contains synthesised pieces of the surface protein that the coronavirus uses to invade human cells, spurring production of antibodies to fight the disease.

The US government agreed last month to pay Novavax $1.6bn to help cover costs related to testing and manufacturing the vaccine, with the aim of procuring 100 million doses by January 2021.

The trial, which began in late May, tested the vaccine on 106 people aged 18 to 59 versus a placebo. The first phase of the study focused on the vaccine’s safety and ability to induce immune responses.

Eight people experienced side effects including a headache, fatigue and muscle pain, but none required medical intervention.

The second phase of the study will be conducted in several countries including the US, though no date has been announced. In addition to safety and immune response, it will gauge the vaccine’s ability to prevent infections or reduce the severity of Covid-19 among a broader range of volunteers.

Gregory Glenn, Novavax’s head of research and development, said that adverse events had been sporadic and spread across patients in both the vaccination and placebo groups in the trial.

At the Moderna webcast on Wednesday the company’s president, Stephen Hoge, said it was difficult to believe the world had not heard of Covid-19 mere months ago, given how much devastation it caused since the first outbreak.

“It is remarkable that this pandemic has harmed millions of people already,” Mr Hoge said, “and our hearts go out to those who’ve lost loved ones or been made sick themselves.”