Moderna Inc has announced that its COVID-19 vaccine will be ready by the end of the year. The drug manufacturer said it is beginning its phase 3 trial consisting of 30 000 participants to demonstrate that the vaccine is safe and effective. This is the final step to be taken before its regulatory approval.
Moderna received nearly $1-billion from the US government to bankroll several vaccine candidates from the country under its “Operation Warp Speed” programme. To date, there are more than 150 COVID-19 vaccines in various stages of development and trial from across the world. According to the World Health Organisation (WHO), there are 25 candidate vaccines in clinical evaluation and 139 candidate vaccines in preclinical evaluation.
Both Pfizer and Johnson & Johnson are in the advanced clinical trial stages of their vaccine candidates, and British pharmaceutical company AstraZeneca Plc is beginning large-scale US trials in conjunction with Oxford University researchers.
“Having a safe and effective vaccine distributed by the end of 2020 is a stretch goal, but it’s the right goal for the American people,” National Institutes of Health (NIH) Director Francis Collins said, announcing the start of Moderna’s phase three trial.
According to Collins, Moderna may have up to tens of millions of doses of the vaccine candidate ready if it is deemed safe and effective. The company plans to deliver an approximate 500-million doses per anum, and this may even go up to 1-billion doses.
The large late-stage trial will evaluate the safety of Moderna’s mRNA-1273 vaccine, and participants will be monitored to determine whether it can prevent symptomatic COVID-19 after just two doses.
The trial volunteers will receive two injections about 28 days apart of either 100 micrograms of mRNA-1273 or a placebo. The results of an early-stage study were published earlier in July, and shows that volunteers who had two doses of the Moderna vaccine had higher levels of virus-killing antibodies than those who had recovered from COVID-19.
Moderna’s vaccine candidate makes use of synthetic messenger RNA (mRNA) to mimic the surface of the coronavirus and teach the immune system to recognize and neutralize it.