Ruminations: The World on Tenterhooks

"So 94 percent of people we have no disease, no symptoms ... Those who get it will be very, very mild and so you will almost stop, if not entirely stop, hospitalization, and death."
"The U.S. has done extremely well. This has been months and months of preparation and planning."
"I don't think the other countries are as ready [to roll out their vaccines]."
"We don’t have a billion-dose manufacturing capacity sitting idle somewhere. We are increasing our output more and more and all our key engineers are working to make that happen."
"So if we pull them out and say, ‘Hey, you have to go and get on a plane on the other side of the world to teach somebody else how to do it,’ they won’t be able to scale up manufacturing in the U.S. or in Switzerland."
Stephane Bancel, CEO. Moderna

This Vaccine against Covid-19 from Moderna would be nearly 95% effective, marking a second major step forward in the quest to end the Covid-19 pandemic. Joel Saget | AFP | Getty Images

So, good for Moderna, good for Pfizer and BioNTech and AstraZeneca, and coming up behind, Johnson & Johnson, and all the other front-runners who have yet to complete their Third-Phase Trials, since it seems the rescue the world is looking for is beginning to arrive. New trial data for Moderna indicate vaccine efficacy rate of 94.2 percent, out-distancing all expectations. That no safety concerns arose is another dose of good cheer. Moderna hopes to produce 500 million to 1 billion doses in 2021.

In Moderna's trial of 30,000 participants [using mRNA-1273] no one vaccinated developed severe COVID-19. Among those study participants who were given a placebo, 30 cases of severe disease and one death arose. The trial included a good number of ethnic minorities, the elderly and people with underlying health conditions. Which would account for those receiving the placebo developing severe disease turned out to be three times higher than what occurred in the placebo portion of the Pfizer-BioNTech trial.

Moderna plans to send its trial data to regulators already reviewing the vaccine, the U.K. included, in addition to filing in the U.S. and E.U for approval. The likely date for the U.S. Food and Drug Administration's advisory group to discuss the Modeerna vaccine would be a week after they analyze the vaccine from Pfizer and BioNTech, around December 17.

The country that has the distinction to become the first in the West to roll out a COVID-19 vaccine is the United Kingdom, with the first Pfizer-BioNTech shots to be given as early as December 7 if all goes as planned. It seemed "highly possible" another developed country would approve the Moderna vaccine before the U.S. Mr. Bancel felt, that perhaps the U.K. or Canada could be the first for an emergency approval to be issued.

It is the United States, however, that has the capability to distribute an approved vaccine within a 24-hour period following approval. Moderna vaccines are produced in Switzerland for the European market, the vaccine made market-ready into vials in Spain, so that the U.K. regulator would have to approve the vaccine prior to it leaving the Spanish factory.

Moderna tracked the average trial participant for at least two months to ensure safety, following FDA guidelines. No serious safety concerns arose. Side effects were inclusive of joint and muscle pain, headaches and fatigue. Last week a large gap between efficacy rates arose with AstraZeneca and the University of Oxford's vaccine data.The efficacy rate turned out to be 62 percent in the largest group of participants with two doses, whereas in the subset of participants under age 55 who were given one-and-a-half doses instead of two, the efficacy rate was 90 percent.

An advantage of the messenger RNA technique Moderna uses along with Pfizer and BioNTech is "strong efficacy across the board", in comparison with the adenovirus-based technology AstraZeneca and Oxford use. "You don't have the same patient-to-patient variability", explained Mr. Bancel of Moderna. Moderna’s vaccine can be kept at –20°C. and once thawed, its vaccine can remain stable for 30 days at 2°C to 8°C, home refrigerator temperatures.

"The data we have are that these vaccines protect you against severe illness, but it doesn’t mean that you can’t get infected and give it to your patient, your neighbor, your customer, or whomever."
Ruth Karron, head, Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health