Saturday, 30 October 2021

Forget Medsafe, adopt FDA recommendation on 5–11-year-old COVID vaccines


“The Government should immediately rule that New Zealand children deserve the same protection as American children and allow the COVID vaccine for 5–11-year-olds, and they should say if it’s possible before school is rumoured to go back on November 15” says ACT Leader David Seymour.

“We certainly hope the Government is not going to say they haven’t ordered the vaccine, hasn’t thought about how to use the doses it has for paediatric administration, or generally hasn’t anticipated that the FDA trial would release results after it’s been going for several months.

“ACT’s COVID 3.0 plan said ‘New Zealanders should have timely access to the best treatments and technologies available to citizens of other countries. Government policy should exempt COVID treatments and technologies from the Medsafe approval process, if a treatment or technology is approved by U.S., Australia, U.K. or E.U.’ Now is the time to activate this policy.

“The FDA has done a trial of 4,700 5-11-year-olds. Three thousand one hundred were given the vaccine (one third of the adult dose) and 1,600 were given a placebo. The study found that the Pfizer vaccine is 90.7 per cent effective at preventing COVID-19.

“The study also investigated safety. For two months, 1444 children were followed after getting the dose. They found symptoms were mild-to moderate, such as sore arms and fevers that lasted less than two days.

“There is no way that Medsafe can replicate what the FDA has done. We don’t have enough COVID in the community to test effectiveness and waiting two months to test safety would give no more reassurance than the FDA already offers.

“The idea that Medsafe is waiting for an application, or data, from Pfizer is madness. The Government should overrule them and say it accepts the Food and Drug Administration’s findings, and vaccinations for 5–11-year-olds can start according to the FDA’s specification immediately.

“All attention should turn to whether the Government is ready with the doses, are they ordered, when are they expected if existing stock cannot be administered paediatrically.

“Clarity around vaccination would give clarity around schools reopening. Getting vaccination for 5–11-year-olds started now would allow time for the nation’s approximately 385,000 primary students to get their first dose before school is rumoured to go back on November 15.

“The vaccine roll out has been struggling to find 10,000 people per day to vaccinate first dose lately, against a high of it has capacity to vaccinate the primary school population in the next two weeks. That would give parents returning their children to school an enormous relief.

“It’s time to apply some common sense to the roll out, we get no value from waiting for Medsafe, the Government should ask the vaccination program to start the roll out for 5–11-year-olds according to FDA regulations now. New Zealand children should have the same protection as Americans.”