"I feel much safer now," Auckland woman Andrea Malcolm told the Herald as she received an approval letter to get her third dose of the Pfizer/BioNTech Covid-19 vaccine.
Malcolm received her third jab this afternoon, administered by her Hobsonville Point GP.
The communications manager was among the first wave of Kiwis to get a third dose after the measure was approved for severely immunocompromised people last Friday.
Malcolm, who had a heart transplant in 2015, takes drugs to suppress her immune system - which stop her body from rejecting her new heart, but also depress the Pfizer vaccine's efficiency.
Now that she has secured her third-jab approval, Malcolm says she feels safer about moving around Auckland as lockdown restrictions are relaxed - and about her eventual return to the office.
A third dose of the Pfizer vaccine has yet to gain MedSafe approval, meaning Malcolm's jab is "off-label" as Ministry of Health guidelines for the immunocompromised put it.
She was required to sign an informed consent letter as part of an exemption process under Section 23 of the Medicines Act.
Malcolm had been seeking information on a third dose after seeing a discussion about its benefits for the immunocompromised in the US - where the Food and Drug Administration approved a third dose for the immunocompromised on August 12.
But until yesterday - when she had her annual checkup on her transplanted heart - Malcolm had had difficulty finding out anything about the availability of a third dose here. During the checkup, a cardiologist was able to give her the approval documentation.
"I was lucky on the timing," Malcolm says.
The Ministry of Health says immunosuppressed people who think they could qualify for the third dose should contact their GP or medical specialist for a prescription letter. The third dose must be taken at least eight weeks after the second.
The severely immunocompromised community includes people who have had organ transplants, and those on certain cancer therapies.
"Individuals who are severely immunocompromised are at a higher risk of severe outcomes from Covid-19 and might not produce a sufficiently strong immune response after two doses of the Pfizer Covid-19 vaccine. A third primary dose may be beneficial," Covid-19 Vaccination and Immunisation Programme national director Jo Gibbs said as she announced her recommendation for a third jab for the immunocompromised on October 22.
"Providing an optional third primary dose to individuals with severe immunosuppression will help protect our most vulnerable against severe disease and hospitalisation if they were to contract Covid-19," Gibbs said.
A spokeswoman for the Ministry of Health could not give even a rough estimate for the size of the group.
"The number of severely immunocompromised people aged 12 and older who qualify for a third primary dose is difficult to quantify. The criteria is complex and needs to be assessed by a medical practitioner to determine whether the patient is eligible. The Ministry of Health estimates that this group is small, and represents a small percentage of the population," she said.
A third jab for all
In the US, the FDA approved a booster shot of the Pfizer vaccine on August 28. Moderna and Johnson & Johnson's vaccines also got the green light for an extra dose.
Earlier today, the FDA said some 15 million Americans have now had a booster shot.
Here, a Ministry of Health spokeswoman emphasised that the third doses for immunocompromised people like Malcolm are a third primary shot, not a booster shot.
"The eligibility criteria to access a third primary dose is complex and applies to only the group of people who are severely immunocompromised," Gibbs said.
"The Covid-19 Technical Advisory Group (CV-TAG) is constantly reviewing the emerging research on booster vaccines, and a recommendation on whether a booster should be offered will be made in the coming months."
Gibbs added, "Cabinet will make a final decision on whether the general public will be able to access a booster vaccine, following Medsafe's assessment once it receives additional data from Pfizer."
The Government previously said the final Pfizer shots would arrive in the country during October.
But in a select committee appearance last month, Covid Response Minister Chris Hipkins "rephased" the final shipments from Pfizer to November and December so they would not expire in the new year. This would allow for vaccinations for the under-12s if approved and booster shots if approved.