Moderna secures extended vaccine supply with Canada, sees regulatory advances
On Monday, August 16, the US biotech reported it had secured a revised supply agreement with the Canadian government for up to 105 million doses of its COVID-19 vaccine and its booster vaccine candidate, if authorized, for delivery through 2024.
The agreement provides for 20 million doses each year in 2022 and 2023, with an option for an additional 15 million doses each year. For 2024, the agreement provides an option for up to 35 million doses.
The development follows the recent news it is to build an mRNA vaccine manufacturing plant in that country.
Vaccine approved for use in UK teens
This week also saw the UK Medicines and Healthcare products Regulatory Agency (MHRA) authorize Moderna’s vaccine for use in 12-17 year old individuals in the UK.
The watchdog confirmed on Tuesday August 17 that the vaccine is safe and effective in that age group.
Dr June Raine, MHRA chief executive, said: “We have in place a comprehensive safety surveillance strategy for monitoring the safety of all UK-approved COVID-19 vaccines and this surveillance will include the 12- to 17-year age group.
“It is for the Joint Committee on Vaccination and Immunization (JCVI) to advise on whether this age group should be vaccinated with the COVID-19 vaccine made by Moderna as part of the deployment program.”
Booster for immunocompromised individuals
Meanwhile, last Friday, August 13, the US Food and Drug Administration (FDA) approved an update to the emergency use authorization for Moderna's vaccine to include a third dose for immunocompromised individuals aged 18 or older in the US.
Such individuals would include those that have undergone solid organ transplantation, or who have been diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
A recent double-blind, randomized controlled trial of 120 individuals who had undergone solid organ transplant procedures (heart, kidney, kidney-pancreas, liver, lung, pancreas) demonstrated that a third dose of the Moderna COVID-19 vaccine improved immune response compared to placebo. In the study, the third dose of mRNA-1273 was generally well tolerated, reported the US company.
Data indicates Moderna shot is robust in dealing with variants
And new data, released on August 12, suggests durability of Moderna’s Covid-19 vaccine against variants of concern and interest.
The paper was published in Science. According to the study, the majority of individuals vaccinated with the Moderna COVID-19 vaccine maintained both binding and functional antibodies against SARS-CoV-2 variants for six months after the second dose.
“We are pleased with these new data showing that people vaccinated with two doses of the Moderna COVID-19 vaccine maintained antibodies through six months, including against variants of concern such as the Delta variant. Along with our partners, we are committed to generating data on the Moderna COVID-19 vaccine and sharing this as available,” said Stéphane Bancel, CEO, Moderna. “These data support the durable efficacy of 93% seen with the Moderna COVID-19 vaccine through six months. We expect that these data and the growing body of real-world evidence will help inform health regulators’ approaches to how and when to administer additional boosting doses.”
This study used a variety of assays and showed that after two doses of the Moderna COVID-19 vaccine, binding and neutralizing antibodies were generated against ancestral strain of the virus and against the variants of concern, Alpha, Beta, Gamma, Delta, Epsilon and Iota, said the company.
While some waning in antibody levels was observed over time, the majority of participants had detectable neutralizing antibody titers at six months after the completion of the primary series, according to the paper.
A trend towards lower antibody levels against SARS-CoV-2 spike variants was observed in the oldest individuals at Day 209. Differences were small, however, and there was overlap between age groups, said Moderna. Importantly, many individuals in the oldest group retained neutralizing activity against the variants six months after the second vaccine dose, added the biotech.