US-based biotechnology firm Moderna Inc said recently that early analysis from its phase 3 trial shows its Covid-19 vaccine is 94.5% effective at preventing the infection, offering hope of a second breakthrough in as many weeks. Together with Pfizer Inc’s vaccine, also shown to be more than 90% effective, and pending more safety data and regulatory review, the US could have two vaccines authorised for emergency use in December with as many as 60 million doses of vaccine available by the year’s end.
Moderna also said its vaccine does not require ultra-cold storage, unlike the candidate announced by Pfizer that has to be stored at temperatures of minus 70 degrees Celsius (-94 Fahrenheit) or below, easing concerns about how to efficiently distribute vaccines to billions of people around the world. Professor Trudie Lang, the director of the Global Health Network at Oxford University, called Moderna’s announcement “very good news indeed.” Moderna now intends to submit for an emergency use authorisation (EUA) with the US FDA. The pharma giant “expects the EUA to be based on the final analysis of 151 cases and a median follow-up of more than 2 months”.
Volunteers in Moderna’s trial were randomly given a two-dose regimen of either Moderna’s experimental shot or placebo injections. The expert panel’s conclusion is based on 95 cases of the disease observed in the study. Out of those 95 illnesses, 90 people on placebo got sick compared to five receiving Moderna’s vaccine. The vaccine also appeared to prevent serious illness. Researchers found 11 cases of severe COVID-19 among the placebo group and zero among people who got the vaccine. In terms of side effects, the news is also quite good. The first dose caused injection site pain in about 3 per cent of people; the second dose was associated with transient generalized symptoms in about 10 per cent of people with fatigue, muscle aches and flu-like symptoms. This seems to indicate that they got the dose about right with acceptable adverse events. These effects are what we would expect with a vaccine that is working and inducing a good immune response.
Stephane Bancel, Chief Executive Officer (CEO) of Moderna said, “This is a pivotal moment in the development of our Covid-19 vaccine candidate. Since early January, we have chased this virus with the intent to protect as many people around the world as possible. All along, we have known that each day matters. This positive interim analysis from our Phase 3 study has given us the first clinical validation that our vaccine can prevent Covid-19 disease, including severe disease.”