TORONTO — Moderna has announced that preliminary data shows its COVID-19 vaccine appears to be 94.5 per cent effective with the company’s chief operating officer saying one of the candidate’s greatest advantages is how it can be stored.
In a interview with CTV News, Moderna’s chief operating officer Ray Jordan explained that the company’s coronavirus vaccine can be stored at standard refrigerator temperatures compared to other candidates. Jordan said this will help eliminate shipping and distribution issues.
“You have the ability to maintain it at -20 degrees Celsius, which is essentially a regular freezer temperature at home or medical freezer temperature for up to six months of which up to 30 days can be at a regular refrigerator temperature,” Jordan said in an interview on Monday.
“It’s pretty consistent with the medical infrastructure that’s used in wholesalers, physician’s offices and pharmacies,” he added.
Last week, competitor Pfizer Inc. announced its own COVID-19 vaccine appeared similarly effective, however, that candidate needs to be kept at -70 C during transportation and storage to remain effective.
While it is exciting to have two COVID-19 vaccine candidates showing promising results, Jordan says the temperature gives Moderna’s an advantage.
“We feel that our vaccine has an attractive quality in terms of how it can be shipped. We understand that some require an ultra cold shipping, ours doesn’t require ultra cold or dry ice or other things that might be more difficult in the distribution,” he said.
Where the two candidates are similar is in their dosage. Both Moderna and Pfizer’s vaccines require two doses, and Jordan said logistics will still need to be arranged, as will who gets the vaccine first.
“I would love to be at the front of that line, but the line needs to be set based on risk of the individuals and the allocation associated with the governments that are providing the vaccine,” Jordan said.
Moderna’s vaccine, created with the National Institutes of Health, is being studied in 30,000 volunteers who received either the real vaccination or a placebo shot. On Sunday, an independent monitoring board examined the 95 infections that were recorded two weeks after volunteers’ second dose. The independent monitoring board found that all but five illnesses occurred in participants who got the placebo, resulting in the 94.5 per cent efficacy.
“Preliminary interim data [shows] very exciting efficacy indications at the levels of the strongest efficacy that can be seen in vaccine is well tolerated by the people in the trial,” Jordan said.
Of the 95 reported infections, 11 were considered severe and all occurred in the placebo group. The independent monitoring board also found that there were no significant safety concerns for the vaccine candidate.
Moderna’s vaccine study is done on a blinded basis, so neither the participant nor the people administering the shot know who received the vaccine or the placebo. Only the independent monitoring board knows who received which shot.
“The direction is to be as careful as you would normally be in society, so that then has the effect of creating the control versus the experimental group,” Jordan explained.
Both Moderna’s shots and the Pfizer candidate are so-called mRNA vaccines and are made without the coronavirus itself, meaning there is no chance anyone could catch it through the vaccine. Instead, the vaccine contains a piece of genetic code that trains the immune system to recognize the spiked protein on the surface of the virus.
While Jordan says Moderna’s results are “very promising,” he acknowledged that the study continues and the protection rate may change as more COVID-19 infections are detected and added to the calculations. Moderna said it is also too soon to know how long protection from its vaccine lasts.
Jordan said Moderna does not have a timeframe for the rest of the study, but participants are expected to be monitored for two years.
The company plans to apply for emergency use of the vaccine in the U.S. in the coming weeks.
The main side effects of the vaccine candidate include fatigue, muscle aches and injection-site pain after the second dose, at rates that Moderna has characterized as more common than with flu shots but on par with others such as the shingles vaccine.
Jordan said most of the side effects reported were mild or moderate and were “very short lived.”
VACCINE ACCESS, PRICE AND STOCK SELLING
Moderna’s vaccine is among 11 candidates in late-stage testing around the world.
Canada has secured access to a total of 414 million doses of COVID-19 vaccines from different sources including 76 million from Pfizer and 56 million from Moderna.
While Moderna expects to have about 20 million doses for the U.S. by the end of 2020, Jordan said he does not know how many doses are destined for Canada in the first round of production.
Jordan said the company has not set a fixed price for the vaccine and is currently negotiating with various countries. He said the vaccine candidate will likely range between US$32 to $37, depending on volumes.
Despite the seemingly good news, stock selling by pharmaceutical companies in charge of producing COVID-19 vaccines has some experts concerned.
The last time that Moderna released positive information about its vaccine candidate, some of the executives in the company sold their stock the same day, raising concerns about profit judging on their product. The same also happen when Pfizer announced the efficacy of its vaccine.
Jordan explained that executive sales of Moderna shares are orchestrated through a program that arranges for trading to automatically happen when the stock hits a certain price.
“What we saw happen was with the price increase associated with the data announcement, it hit some of the triggers that executives had for selling,” he said.
Despite concerns that the sale of shares following the announcement of positive results may show a lack of confidence in the vaccine, Jordan said that is “absolutely not” the case with Moderna.
“The sales were not as you might think of calling a broker and saying, ‘Sell some now.’ They were these programs that [were] put in place in prior weeks, months, or years that were triggered,” he said.
While the issue of stock selling has raised red flags for some, others are worried about companies rushing to achieve a COVID-19 vaccine without following scientific protocols.
Moderna’s recent results are just an interim analysis, and Jordan says the company plans to go through the proper channels to ensure the results of its trials are scientifically reviewed.
“Our intention is to ultimately provide full analysis to a peer review journal, which is consistent with what we’ve done with our Phase 1 trial,” Jordan said, adding that portions of the review for its Phase 1 data have already been completed.
However, he says reviews of Phase 2 and 3 results will take time, as those trials are still underway.
While Moderna is confident with the results of its vaccine so far, that doesn’t mean the company will soon be shipping out doses.
Jordan says Moderna is still waiting on the clinical trial to know for certain if the vaccine is safe.
“Until you run the clinical trial and see what happens in the real world, you don’t know for certain so certainly we were on pins and needles waiting to see what this looks like,” he said.