US drug companies Moderna and Novavax close in on vaccine

Two US pioneers in the battle to produce a Covid-19 vaccine announced progress, with drug manufacturer Moderna revealing yesterday it was stockpiling its candidate in anticipation of regulatory approval.

Revealing its second-quarter results of $3.1 billion (Dh11.38bn), the biotech company’s chief executive, Stephane Bancel, confirmed it was on track to supply 500 million doses a year from 2021.

He said the price of any approved product would make it widely accessible during the pandemic.

Mr Bancel said discussions over supply agreements had begun with the governments of several countries, and that Moderna had received about $400 million in customer deposits for a potential supply.

“I can tell you that as we speak our teams are making commercial products assuming the potential approval of mRNA1273,” Mr Bancel said.

“We are literally making products and stockpiling them at risk.”

An early trial of Moderna’s pioneering messenger RNA vaccine candidate 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 candidate 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 when Novavax intends to begin a large Phase 3 trial.

The US company announced on Tuesday that its experimental vaccine had produced high levels of antibodies against the coronavirus 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 candidate contains synthesised pieces of the surface protein that the virus 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 against a placebo. The first phase of the study focused on safety and immune-system response.

Eight people experienced side effects including a headache, fatigue and muscle pain, but none needed treatment.

The second phase of the study will gauge the vaccine’s ability to prevent infections or reduce the severity of Covid-19 among a more diverse cohort of volunteers.

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