US regulator sets date to evaluate Moderna vaccine for emergency use

By Mario Villar

New York City, Nov 30 (efe-epa).- As United States biotech firm Moderna announced Monday that its vaccine shows efficacy of 94.1 percent against COVID-19 and 100 percent against severe cases, and the US Food and Drug Administration (FDA) set a date to discuss its emergency usage request.

“We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations and death,” said Moderna’s chief executive officer Stéphane Bancel in a statement, adding that the company was to request emergency use authorization.

The FDA, which oversees the commercialization of medicines in the US, later Monday said that its Vaccines and Related Biological Products Advisory Committee of scientists and public health experts would meet on Dec. 17 to discuss Moderna’s request.

The company, which had already announced the results of its Phase 3 clinical trials on Nov. 16, on Monday confirmed the effectiveness of its vaccine and becomes the second US company, after Pfizer, to request emergency authorization to start selling its product, known as mRNA-1273.

If there are no problems during that approval process, it is expected that the two vaccines can begin to be administered this year.

In the case of Moderna, the first injections could be given as soon as Dec. 21, Bancel said in an interview with the New York Times.

The company recruited more than 30,000 participants for the study, in which some volunteers were given the vaccine and others a placebo, before being followed up to see if they had been infected with the novel coronavirus and if so, what symptoms they developed.

The data presented by Moderna Monday shows 196 cases of infection with the SARS-CoV-2 coronavirus, including 185 patients who had received the placebo and 11 who had been vaccinated.

Of the total, 30 developed severe cases and one of those died, all of them within the placebo group, which is why Moderna attributes to its vaccine a 100 percent effectiveness in preventing serious clinical conditions.

According to Bancel, the analysis confirms the ability of mRNA-173 to prevent COVID-19 with an efficacy of 94.1 percent and to completely prevent severe cases.

The biotechnology company also pointed out that the efficacy of the vaccine is “consistent across age, race and ethnicity, and gender demographics” and that, although continuous reviews of safety data are ongoing, “no new serious safety concerns have been identified.”

Moderna said that, based on a prior analysis, the most common adverse reactions when the vaccine was administered included pain and redness at the injection site, fatigue, myalgia, arthralgia and headache.

The Phase 3 study developed by the company has already exceeded the average two-month follow-up after vaccination, as required by the FDA for authorization of emergency use.

Thus, Moderna’s vaccine ranks similar to that of Pfizer and its German partner BioNTech in the run-up to approval and offers a new option for starting vaccination against the disease as soon as possible.

Pfizer has said it expects to be able to make 50 million doses in the remainder of 2020 and 1.3 billion more in 2021, while Moderna has said it will have 20 million for use in the US this year and will produce between 500 million and 1 billion globally next year.

Both vaccines use messenger RNA (mRNA) technology, however, Moderna’s has an advantage as it can be kept for 6 months at -20 Celsius, although is expected to be stable for 30 days at normal refrigerator temperatures. Pfizer’s requires storage at -70C, so the transport and storage of Moderna’s is expected to be cheaper and more accessible to rural areas or developing economies.

However, its selling price is expected to be somewhat more expensive at around $33 per dose – and much higher than the vaccine being developed by Oxford University and AstraZeneca ($4 per dose), which have also committed to offering it “on a not-for-profit basis for the duration of the pandemic across the world, and in perpetuity to low- and middle-income countries.”

This vaccine, which has shown an efficacy of up to 90 percent in tests, is one of the great hopes for many countries, but has raised some doubts because of the way in which clinical trials have been developed. Other vaccines that are already being used in China or the Russian Sputnik V also stand out.

Moderna’s Monday announcement boosted the firm’s shares on Wall Street, which ended the day up 20.24 percent. The shares of the company have now climbed close to 700 percent so far this year. EFE-EPA