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European regulators weigh in on COVID-19 vaccine boosters
Filed Under:
COVID-19
Lisa Schnirring | News Editor | CIDRAP News
| Oct 04, 2021
The European Medicines Agency (EMA) today released the results of its human medicine committee's recent deliberations on COVID-19 boosters and third doses, concluding that an extra dose of the Pfizer-BioNTech and Moderna vaccines can be given to people with severely weakened immune systems.
Group also looking at Moderna booster data
In a statement, the group said it's important to distinguish between the extra dose for people with weakened immune systems and boosters for people without compromised immune systems.
For the extra dose in people with severe immune compromise, the EMA recommends that the third dose be given at least 28 days after the second dose. It based its recommendation on studies in organ transplant patients, which suggested that an extra dose increased the ability to make antibodies. The group added that though there's no direct evidence that the ability to produce antibodies protected them against COVID-19, an extra dose probably increases production in at least some patients.
Regarding the booster issue for people with healthy immune systems, they looked at data for the Pfizer-BioNTech vaccine in adults ages 18 to 55 who showed a rise in antibody levels when given a booster dose 6 months after the second dose. They concluded that booster doses may be considered at least 6 months after the second dose for those ages 18 and older.
Committee members noted that inflammatory heart conditions and other rare side effects after booster dose administration aren't known, but are being carefully monitored. Officials said they are currently reviewing booster dose data for the Moderna vaccine.
More global headlines
European regulators weigh in on COVID-19 vaccine boosters
Filed Under:
COVID-19
Lisa Schnirring | News Editor | CIDRAP News
| Oct 04, 2021
The European Medicines Agency (EMA) today released the results of its human medicine committee's recent deliberations on COVID-19 boosters and third doses, concluding that an extra dose of the Pfizer-BioNTech and Moderna vaccines can be given to people with severely weakened immune systems.
Group also looking at Moderna booster data
In a statement, the group said it's important to distinguish between the extra dose for people with weakened immune systems and boosters for people without compromised immune systems.
For the extra dose in people with severe immune compromise, the EMA recommends that the third dose be given at least 28 days after the second dose. It based its recommendation on studies in organ transplant patients, which suggested that an extra dose increased the ability to make antibodies. The group added that though there's no direct evidence that the ability to produce antibodies protected them against COVID-19, an extra dose probably increases production in at least some patients.
Regarding the booster issue for people with healthy immune systems, they looked at data for the Pfizer-BioNTech vaccine in adults ages 18 to 55 who showed a rise in antibody levels when given a booster dose 6 months after the second dose. They concluded that booster doses may be considered at least 6 months after the second dose for those ages 18 and older.
Committee members noted that inflammatory heart conditions and other rare side effects after booster dose administration aren't known, but are being carefully monitored. Officials said they are currently reviewing booster dose data for the Moderna vaccine.
More global headlines
- New Zealand's Prime Minister Jacinda Ardern today announced a plan to gradually ease COVID-19 restrictions in Auckland, the country's hot spot, where a small but steady stream of cases continue to be reported, according to NPR. She said keeping cases close to zero with strict measures was important when a vaccine wasn't available and that the country can now change its approach. Two cases were recently detected about 90 miles south of Auckland in the Waikato region, prompting a 5-day circuit-breaker lockdown, according to Reuters.
- Elsewhere in the region, Australia reported Delta (B1617.2) variant cases in two more states. They include Tasmania, which reported its first case in 58 days, and South Australia state, according to Reuters.
- Some countries in Asia—including Thailand, South Korea, Taiwan, and Malaysia—are in talks with Merck to purchase courses of its experimental COVID-19 antiviral molnupiravir.
- The global COVID-19 total just topped 235 million cases, rising to 235,239,219 cases, according to the Johns Hopkins online dashboard. So far, 4,806,199 people have died from their infections.