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Ireland could receive the first shipment of a Covid-19 vaccine later this year, the Irish Independent has learned.
Aul Reid, managing director of Pfizer Ireland, believes there are strong indications that his company’s experimental jab could be approved for emergency clearance by the end of next month. You already have 100 million doses manufactured and ready to use if you get the green light from regulatory agencies in the United States and Europe.
He told the Irish Independent that Pfizer and its German partner BioNTech are now in talks with the European Commission to work out an advance purchase agreement that would allow member states, including Ireland, to get a share of the first deliveries.
“We can have 100 million doses by the end of 2020. If we have an advance purchase agreement with the EU Commission, that is assured. Part of that would include a volume that we believe we can make available across Europe.”
The vaccine includes two doses and is being tested in 44,000 people of all ages.
“We are accelerating the clinical trial program at breakneck speed. We are seeing recruitment rates in trials that we have never seen before. 40,000 have already been recruited. We have more than 35,000 participants who received the second dose of the vaccine.”
Several hurdles must be overcome before it is ready to be administered to the public.
The first stage is to submit it for emergency use authorization to the FDA in the United States early next month and to the European Medicines Agency shortly thereafter.
“The FDA will review the data with its own scientists. It will be reviewed by an external panel of independent experts at a public meeting,” he said. As part of the fast track approach, the company has been submitting its data to the European licensing authority continuously since testing began.
Typically this information is provided at the end of clinical trials.
“Once it’s available, it’s handed over to them for review,” Reid said, adding that security is crucial.
“We will have to demonstrate the quality and consistency of the vaccine.”
Reid said the company had been investing since the early days of the pandemic to ensure its manufacturing processes were ready to meet the capacity demands needed to manufacture the levels of vaccine that would be ordered.
He revealed that the results were very promising.
“We are trying to be as open as possible. We are sharing any conclusive reading data, positive or negative, within days after independent scientists see it.”
“The positivity around the vaccine is based on good science so far.”
One of the tests of any Covid vaccine will be its efficacy and performance in various age groups. The Pfizer candidate has been tested on participants 12 years of age and older.
Staff at the Pfizer Grange Castle site in West Dublin have participated in quality testing to support the manufacture of the jab in Belgium.
The EU Commission, with funding from member states, has already entered into advance purchase agreements with three other companies hoping to produce a successful vaccine, including experimental injections from Oxford-AstraZeneca, Sanofi and Johnson & Johnson.
But now it appears that Pfizer is in pole position to be the first to cross the finish line.
If early batches of a successful vaccine are shipped here, the government will decide who should receive the injection first, based on advice from its immunization advisory group.
Front-line healthcare workers and groups at risk, such as nursing home residents, would likely be first in line.
Reid said the plan was to produce 1.3 billion doses next year. One of the challenges will be to produce the volume of vaccines required for such global demand.
The initial launch of the vaccine will still mean that physical distancing and other Covid rules will have to be followed.
But since groups at risk receive some protection, depending on their effectiveness, the need for blockades will decrease.
Online editors
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