Results from an early stage clinical trial of Moderna's coronavirus vaccine candidate, mRNA-1273, demonstrated effectiveness in older participants in the age groups of 56 to 70 and 71 and above. The study, published in the New England Journal of Medicine on Tuesday, gave researchers a clearer picture on how the vaccine would work on a broader population.
The study was an extension of Moderna's preliminary trials to test the safety and effectiveness of the potential vaccine. Participants over the age of 56 received two doses of the shot--either at 25 micrograms or 100 micrograms--28 days apart. The results showed that older individuals produced the same levels of neutralizing antibodies as younger participants when given the 100 microgram dose.
However, many participants in the study experienced side effects, ranging from headaches to injection site pain. These types of side effects are generally classified as mild to moderate and are similar to an average flu vaccine. A few older participants had developed severe reactions, like high grade fevers and severe fatigue.
One of the study's lead researchers, Dr. Evan Anderson, told Reuters in a phone interview that side effected occurred soon after injection of the vaccine candidate and "resolved quickly."
Side effects aside, the results from the early study demonstrate that Moderna's candidate may be effective in older populations, which are a group whose immunity generally weakens with age. Older populations are also more susceptible to severely or life-threatening coronavirus infection, which makes vaccine effectiveness even more important.
The biotech is currently conducting large-scale clinical trials of the vaccine candidate at the 100 microgram level.
Additionally, Moderna's CEO Stephane Bancel told the Financial Times in an interview on Wednesday that the biotech does not plan to apply for an emergency use authorization from the U.S. Food and Drug Administration (F.D.A.) for mRNA-1273 until late November.
"November 25 is the time we will have enough safety data to be able to put into an [emergency use authorization] file that we would send to the F.D.A.--assuming that the safety data is good, [for example] a vaccine is deemed to be safe," Bancel stated.
The company does not expected to have full regulatory approval to widely distribute the vaccine until spring 2021.
"No-Sail" Overruled
The Trump administration has blocked a new order from the U.S. Centers for Disease Control and Prevention (C.D.C.) that planned to extend the agency's "no sail" policy on cruises from U.S. ports until February, according to Axios sources familiar with the manner.
The agency's current "no sail" policy, which was enacted in April and later extended as the coronavirus pandemic continued, is set to expire on Wednesday. The report stated that the Trump administration plans to extend the order until the end of October, which is in-line with the cruise industry's volunteer ban.
Moving forward, the government plans to hold talks with representatives from major cruise lines--including Norwegian Cruise Line (NYSE: NCLH) and Royal Caribbean (NYSE: RCL)--to plan coronavirus safety measures. Possible health and safety mandates that may be issued for the industry could include mandatory masks in public spaces and negative coronavirus test results required before a passenger can board the vessel.