CORONAVIRUS | U.S. FDA Advisory Panel Sets Stage For Moderna Vaccine Authorization

The U.S. Food and Drug Administration (FDA) will ‘rapidly’ work towards granting emergency approval of Moderna Inc’s COVID-19 vaccine candidate, FDA Commissioner Stephen Hahm said on Thursday.

A panel of outside advisers to the FDA overwhelmingly endorsed the emergency use of Moderna’s coronavirus vaccine on Thursday, virtually assuring a second option for protecting against COVID-19 for a pandemic ravaged nation.

The committee voted 20-0 with one abstention that the benefits of the vaccine outweighed its risks in people aged 18 and older.

A week ago, the same panel backed a vaccine from Pfizer Inc and German partner BioNTech SE, leading to an FDA emergency use authorization (EUA) a day later.

Following Hahn’s comments, the Financial Times reported that the FDA had decided to approve Moderna’s vaccine candidate on an emergency basis. It cited people close to the process and added that the emergency approval will be granted in coming days.

The FDA and Moderna did not immediately respond to requests for comment on the Financial Times report.

The FDA si expected to grant EUA late on Thursday or Friday.

EASIER TO TRANSPORT AND STORE

Modern’a vaccine does not require specialized ultra – cold freezer or vast quantities of dry ice, unlike Pfizer’s vaccine which needs to be shipped and stored at -70 Celsius (-94F), making it easier to supply rural and remote areas. 

Moderna said on Thursday it had expanded the vaccine’s handling guidance to allow it to be moved locally in a liquid state at standard refrigerated temperatures. In some cases, Moderna said, this could be the only practical way to move it to clinics or remote locations.

U.S. officials have said they expect to have 40 million does of the Pfizer/BioNTech and Moderna vaccines by the end of the year – enough to inoculate 20 people. Both vaccines were about 95% effective at preventing illness in pivotal clinical trials with no serious safety issues.

The first wave of doses are expected to be earmarked for healthcare workers who treat COVID-19 patients and vulnerable residents and staff of nursing homes. The Moderna vaccine, based on new synthetic messenger RNA (mRNA) technology, is administered in two shots about 28 days apart. The Pfizer/BioNTech shot is also an mRNA vaccine.

Documents prepared by FDA scientists and released ahead of the meeting, said a two – dose regimen of the Moderna vaccine was highly effective preventive in preventing COVID-19 and did not raise any specific safetly issues.

There were no cases of severe COVID-19 among those who got the vaccine in the trial versus 30 such cases in the placebo group, which could be significant as hospital intensive care units fill with infected patients.

The United States in August entered a $1.5 billion pact with Moderna to acquire 100 million does  of its vaccine.

About 20 million does are expected to be delivered this month, with the rest of the initial purchase coming in the first quarter of next year. Last week, Moderna agreed to deliver an addition 100 million doses in the second quarter.

In the global race to produce highly effective vaccines against the coronavirus, the Massachusetts – based biotech company  is reaching the finish line ahead of some much larger rival such as AstraZeneca Pla and Johnson $ Johnson.

An emergency meeting of a U.S Centers for Disease Control and Prevention advisory panel is expected to follow the FDA’s authorization of Moderna’s vaccine with its official recommendation of its use for the U.S. public.