{"id":19699,"date":"2021-02-03T07:08:41","date_gmt":"2021-02-03T07:08:41","guid":{"rendered":"https:\/\/www.radiofree.org\/?p=157674"},"modified":"2021-02-03T07:08:41","modified_gmt":"2021-02-03T07:08:41","slug":"nzs-medsafe-grants-pfizer-biontech-covid-vaccine-provisional-approval-2","status":"publish","type":"post","link":"https:\/\/radiofree.asia\/2021\/02\/03\/nzs-medsafe-grants-pfizer-biontech-covid-vaccine-provisional-approval-2\/","title":{"rendered":"NZ\u2019s Medsafe grants Pfizer-BioNTech covid vaccine provisional approval"},"content":{"rendered":"

By RNZ News<\/a><\/em><\/p>\n

New Zealand\u2019s medicines regulator Medsafe has provisionally approved the Pfizer-BioNTech vaccine against covid-19, with certain conditions placed on the company.<\/p>\n

In its assessment of the vaccine, the regulator met with the Medicine Assessment Advisory Committee (MAAC) for six hours yesterday to receive advice and recommendations.<\/p>\n

In a statement, Medsafe said the MAAC supported the decision.<\/p>\n

However, the provisions mean the company must meet 58 conditions that are placed on it.<\/p>\n

\u201cOf these, 52 relate to requiring additional manufacturing data from the company, for instance as it upscales its manufacturing,\u201d Medsafe group manager Chris James said.<\/p>\n

\u201cSix of the conditions relate to additional clinical information such as regular updates from clinical trials, and ensuring we receive any information on safety concerns from around the world.\u201d<\/p>\n

Medsafe had given Pfizer timeframes to respond on the conditions, and was keeping an open dialogue with the company, he said.<\/p>\n

Same vaccine batch as in Australia<\/strong>
New Zealand\u2019s Pzifer vaccines are coming in by air and will be from same batch as Australia\u2019s. A batch of 450,000 doses was expected by the end of March.<\/p>\n

The vaccines will go into nine large freezers in Auckland and Christchurch when it arrives on shore, then it will be distributed around the country using cold-chain storage, which keeps it at -70C.<\/p>\n

Director-General of Health Dr Ashley Bloomfield said it would then go into short-term storage at between 2C to 8C, where it would remain usable for up to five days.<\/p>\n

\u201cSo the co-ordination of getting appointments and making sure we\u2019re using the vaccine and none is going to waste is a really big effort,\u201d he said.<\/p>\n

After the vaccine has been administered, people will need to wait 30 minutes to mitigate any potential side effects. People will receive two doses, three-to-four weeks apart.<\/p>\n

Asked about the effectiveness of vaccines against new strains of covid-19, Dr Bloomfield was optimistic.<\/p>\n

\u201cSo far, certainly with the strain first identified in the UK, the results are promising. It appears to be for the vaccines for the couple of vaccines that have looked at this \u2013 that the variant first found in South Africa does have a reduced effectiveness for the vaccines. But it\u2019s still highly effective for the ones they\u2019ve tested,\u201d he said.<\/p>\n

However, he warned the situation could become more complicated over time, as more strains emerge.<\/p>\n

\u201cWhen people are immunised against the existing strains, the virus will try to find a way to get around the vaccine,\u201d he said.<\/p>\n

PM outlines who will get vaccine first
<\/strong>Speaking at Waitangi, Prime Minister Jacinda Ardern said the vaccine was expected to arrive in the first quarter of the year, but could not put a firm date on when.<\/p>\n

Prime Minister Jacinda Ardern \u2026 every New Zealander will be able to be vaccinated. Image: Dan Cook\/RNZ<\/div>\n

Once here, it would be \u201cready for use, ready for rollout\u201d, with hotel cleaners, security guards and border workers at the airport among those at the front of the queue.<\/p>\n

\u201cThose most at risk of getting Covid-19 will receive the vaccine first, with the broader community accessing the vaccine from the second half of the year,\u201d Ardern said.<\/p>\n

\u201cSubject to expected delivery of the first batch of the vaccine, we will start vaccinating first our border workers and the people they live with. People such as cleaners, the nurses who undertake health checks in MIQ, security staff, customs and border officials, airline staff and hotel workers will be among the first to get the vaccine.\u201d<\/p>\n

It has been approved for people 16 years and older, with two doses 21 days apart.<\/p>\n

Ardern encouraged all to get vaccinated and said people could have confidence in the vaccine and the process followed by Medsafe to approve it.<\/p>\n

\u201cI have said 2021 is the year of the vaccine. It\u2019s a full-year programme we have only just begun. We\u2019re not in a race to be first, but to ensure safe and timely access to vaccines for all New Zealanders,\u201d she said.<\/p>\n

\u2018Getting vaccinated will save lives\u2019
<\/strong>\u201cGetting vaccinated will save lives, and this is the next job of the team of five million.\u201d<\/p>\n

Minister in charge of the Covid-19 Response Chris Hipkins said: \u201cFollowing Medsafe\u2019s approval, Ministry of Health officials will give advice to the government this week about the \u2018decision to use\u2019 the vaccine. This will essentially set out who are most suited to receive the Pfizer-BioNTech vaccine, such as age ranges.\u201d<\/p>\n

The first Pfizer-BioNTech vaccines were expected to arrive in New Zealand by the end of the first quarter, he said.<\/p>\n

\u201cOnce vaccination of our border workers starts, we expect it to be completed within two to three weeks.\u201d<\/p>\n

At a media conference in the afternoon, it was announced a new government advisory group established to identify issues pertinent to vaccine administration was scheduled to meet tomorrow.<\/p>\n

Meetings will be convened by Ministry of Health chief science adviser Ian Town. The scientists will keep ministers informed on the framework used to administer four different vaccines, including who should receive these and under what circumstances.<\/p>\n

Provisional approval is \u2018significant milestone\u2019 \u2013 Bloomfield
<\/strong>Medsafe said it would continue to monitor use of the vaccine in the country including analysis of any potential side effects, which it said may include a sore arm or headaches as with other vaccines.<\/p>\n

Medsafe group manager Chris James said a full assessment on the vaccine\u2019s safety, effectiveness and quality \u2013 to guide the approval decision \u2013 started in November last year.<\/p>\n

\u201cThe data was provided on a rolling basis, which streamlined the assessment process and enabled a timely approval without compromising the rigour of the review of the vaccine,\u201d he said.<\/p>\n

\u201cAll the data is considered and we then complete a benefit risk assessment, which allows us to balance the benefits of the vaccine against any known risks such as side effects. We have determined there may be some minor side effects such as a painful arm and headaches \u2013 these are not uncommon in other vaccines.<\/p>\n

\u201cWe have also wanted to ensure the company can manufacture the vaccine to a high quality, and that all batches are consistent.\u201d<\/p>\n

Medsafe\u2019s website includes more information on the vaccine, including the medicine data sheet and full list of ingredients. Other details specifically tailored for consumers will also be published.<\/p>\n

New chapter in NZ response<\/strong>
In the statement, Dr Bloomfield said the decision brought about a new chapter in New Zealand\u2019s response to the pandemic.<\/p>\n

\u201cI want to reassure New Zealanders we will also be applying the same rigour to all subsequent vaccine applications.\u201d<\/p>\n

In a conference in the afternoon, James said despite the data process being streamlined, it had in no way compromised assessment standards.<\/p>\n

\u201cWe have not cut any corners in assessment,\u201d he said.<\/p>\n

The same process would be used with the other three vaccines.<\/p>\n

The Oxford-AstraVeneca vaccine data had been rolling in and an application for approval had been received by Medsafe this week, James said.<\/p>\n

The Janssen vaccine was also progressing well, with data being submitted and an application for approval expected during the second-quarter of the year, he said.<\/p>\n

No Novavax application<\/strong>
No application had been received for the Novavax vaccine.<\/p>\n

Four separate teams of assessors had been allocated to look at the vaccines.<\/p>\n

James admitted that data received from clinical trials and reports from overseas regulatory partners didn\u2019t confirm that any of the vaccines reduced transmission. Manufacture of the vaccines is primarily used in Belgium, Germany and the US.<\/p>\n

While Dr Bloomfield highlighted the decision as a \u201csignificant milestone\u201d, he warned: \u201cThere is more work to do, we are not out of the woods yet.\u201d<\/p>\n

\u201cVaccination is a key next step in our ongoing response to this virus. It\u2019s also a good point to recognise the incredible amount of work New Zealanders have put in to support our successful response to date.\u201d<\/p>\n

Dr Bloomfield said as soon as authorities were confident about the vaccine\u2019s arrival date, it would be made public.<\/p>\n

Previously, he said he was confident that New Zealand<\/a> would receive a Covid-19 vaccine by the end of March.<\/p>\n

\u2018Ready to start\u2019<\/strong>
\u201cWe will be ready to start vaccinating people as soon as a vaccine arrives, and at this time the first vaccine we\u2019re expecting is Pfizer in this quarter,\u201d he said.<\/p>\n

Last week, Pfizer said in a statement it was on track to deliver the first doses to New Zealand<\/a> in February, and committed to its agreement to supply 1.5m doses during 2021.<\/p>\n

If delays with Pfizer\u2019s vaccine were to occur, New Zealand had other vaccines to fall back on, Bloomfield said. New Zealand has agreements with AstraZeneca, Novavax and Janssen as well for the Pfizer-BioNTech vaccine.<\/p>\n

Australia approved the Pfizer product last week. BioNTech and Pfizer this month raised their supply goal for this year to 2 billion doses, up from a previous aim of 1.3 billion.<\/p>\n

This article is republished under a community partnership agreement with RNZ.<\/em><\/p>\n

\"Print<\/a><\/div>\n\n

This post was originally published on Radio Free<\/a>. <\/p>","protected":false},"excerpt":{"rendered":"

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