A COVID-19 vaccine being tested in New Hampshire has been approved for use in the United Kingdom, where developers believe it will be effective against a new variant of the virus, but that doesn’t change the local trial.
“It won’t end because they need to collect as much data as they can on everybody participating,” said Terry Stubbs, CEO of ActivMed, the Portsmouth company overseeing the New England trial for British pharmaceutical firm AstraZeneca.
Stubbs said 1,250 people from New Hampshire, Maine and Massachusetts have signed up for the Phase 3 clinical trial, which is now closed to new participants. They will get two shots about 30 days apart and their health will be monitored for two years. Two-thirds received the vaccine and one-third got a neutral shot known as a placebo to allow for a more accurate comparison.
Phase 3 trials are the final step before a vaccine can be released in the United States, although the Food and Drug Administration can allow their use early under emergency declarations, as happened with the Pfizer and Moderna vaccines and will probably happen with AstraZeneca's vaccine.
As an example of why clinical trials continue for years, Stubbs pointed to a trial of influenza vaccine that ActivMed helped run, which discovered an issue with some patients as the months went by.
“We found over time that individuals over the age of 65 didn’t metabolize the regular dose of the vaccine. They actually needed a double dose – that’s why there’s a stronger dose of flu vaccine for people over 65,” she said.
“The idea is to have as much data as we can get toward FDA approval. It will probably get emergency approval, but there still needs to be long-term data collected,” Stubbs said.
ActiveMed’s site is one of 100 locations in the U.S. running the Phase 3 trial.
The vaccine developed by AstraZeneca and University of Oxford vaccine was approved Tuesday by British health authorities, who have ordered 100 million doses. The first inoculations will be given Monday.
Great Britain has sped up approval and rollout of this vaccine because a mutation of the COVID-19 virus is more contagious, leading to outbreaks of disease which have forced the government to extend lockdowns to three-quarters of England’s population.
This vaccine could be more useful in less developed parts of the world than vaccines from Pfizer and Moderna, which have already received emergency approval for use in the U.S. because it is relatively inexpensive to make and can be kept in refrigerators rather than at ultra-cold or freezer temperatures.
The Moderna and Pfizer vaccines are based on messenger RNA, genetic material that creates certain proteins which are also made by the CoV2-SARS coronavirus. Creating these proteins “teaches” the patient’s immune system to recognize them so when the coronavirus shows up, the immune system will react quickly.
By contrast, AstraZeneca’s vaccine uses a weakened version of a common cold virus to teach the immune system. That is the most common way to develop a vaccine but it takes longer in development using messenger RNA.
ActivMed is a private company that runs clinical trials under protocols approved by the National Institutes of Health. Founded near Boston, it expanded into the Portsmouth about 8 years ago. The company has 45 employees in four locations.(David Brooks can be reached at 369-3313 or firstname.lastname@example.org or on Twitter @GraniteGeek.)