By Praveen Menon
WELLINGTON (Reuters) - New Zealand reported its first recorded death linked to the Pfizer/BioNTech COVID-19 vaccine, the health ministry said on Monday, after a woman suffered a rare heart muscle inflammation side effect.
The report comes as the country battles an outbreak of the Delta variant of the coronavirus after nearly six months of being virus free. It followed a review by an independent panel monitoring the safety of the vaccines.
"This is the first case in New Zealand where a death in the days following vaccination has been linked to the Pfizer (NYSE:PFE) COVID-19 vaccine," the ministry said in a statement, without giving the woman's age.
The vaccine monitoring panel attributed the death to myocarditis, a rare, but known, side effect of the Pfizer vaccine, the ministry added.
The board said the myocarditis "was probably due to vaccination", according to the ministry. The health ministry said other medical issues at the same time could have influenced the outcome after vaccination.
Myocarditis is an inflammation of the heart muscle that can limit the organ's ability to pump blood and can cause changes in heartbeat rhythms.
Pfizer said it recognised there could be rare reports of myocarditis after vaccinations, but such side effects were extremely rare.
"Pfizer takes adverse events that are potentially associated with our vaccine very seriously," the company said.
"The benefits of vaccination with the Pfizer COVID-19 vaccine continue to greatly outweigh the risk of both COVID-19 infection and vaccine side effects, including myocarditis," Pfizer said.
Regulators in the United States, the European Union and the World Health Organization have said that mRNA vaccines from Pfizer with German partner BioNTech and by Moderna (NASDAQ:MRNA) are associated with rare cases of myocarditis or pericarditis, an inflammation of the lining around the heart, but that the benefits of the shots outweigh any risks.
The cases, affecting mainly younger men, tend to be mild and treatable but can lead to serious illness and hospitalization.
There have been no U.S. deaths reported for young adults who developed myocarditis after being given the mRNA vaccines, the U.S. Centers for Disease Control and Prevention (CDC) said on Monday.
Separately, it also said that a total of 2,574 U.S. cases of myocarditis or pericarditis had been reported. More than 330 million doses of the Pfizer/BioNTech and Moderna vaccines have been administered in the United States.
The risk of myocarditis was 18.5 per million doses given among people aged 18 to 24 after their second Pfizer dose and 20.2 per million for that age group among Moderna second dose recipients. The risk decreases with age, according to the CDC analysis based on its national reporting system.
The EU's drug regulator said on July 9 that five people had died due to the heart side effect after receiving either of the two mRNA vaccines in the European Economic Area, all of whom were elderly or had other diseases. More than 200 million mRNA doses have been administered in the region.
New Zealand has provisionally approved use of the Pfizer/BioNTech, Johnson & Johnson (NYSE:JNJ) and AstraZeneca (NASDAQ:AZN) vaccines, but only the Pfizer vaccine has been approved for rollout to the public. More than 3 million doses have been given so far, mostly to people over 50.
New Zealand reported 53 new COVID-19 cases on Monday, taking its tally of infections in the current outbreak to 562, amid a nationwide lockdown enforced this month to limit spread of the Delta variant.