Results of the Pfizer vaccine safety and immunogenicity in pregnant women

Erika Whittome made this Official Information request to Ministry of Health

Currently waiting for a response from Ministry of Health, they must respond promptly and normally no later than (details and exceptions).

From: Erika Whittome

Dear Ministry of Health,
This study C4591015 on pregnant women is listed in the Medsafe Risk Management Report https://www.medsafe.govt.nz/COVID-19/Com...

"To assess safety and immunogenicity in pregnant women.
In addition, exploratory objectives include:
(a) To describe the immune response in infants born to breastfeeding
women vaccinated with prophylactic COVID-19 mRNA vaccine during
pregnancy.
(b) To describe the safety of maternal immunisation in infants born to
breastfeeding women who received COVID-19 mRNA vaccine during
pregnancy. "

According to Pfizer, C4591015 was Completed 7–15-2022

Please would you share the results of the study C4591015 and the MoH's (or other agency's) review of this study as captured in meeting minutes, memos or any other correspondence?

Specifically I refer to all the information the MoH holds on C4591015 since the study's completion in 2022 and the study's results on pregnant women and breastfed infants.

Yours faithfully,

Erika Whittome

Link to this

Things to do with this request

Anyone:
Ministry of Health only: