Construction problems prevent opening vaccine facility on schedule
OTTAWA – Construction problems delayed plans for a National Research Council manufacturing facility that could be making one of the leading COVID-19 vaccine candidates, but the facility also had no vaccine to produce after a controversial deal with China fell apart.
Early in the pandemic, the government invested $44 million to create a vaccine production capability at the National Research Council’s facility on Royalmount Avenue in Montreal. The original plan was part of a partnership with Cansino biologics, a Chinese firm that partnered with the NRC previously on an ebola vaccine.
The small facility was planned in two phases, one a temporary set-up that would allow Canada to produce the thousands of doses of vaccine to participate in a trial with Cansino’s. This would be followed by a permanent facility in a separate part of the same building.
The NRC worked on both the temporary facility and the permanent one at the same time, but in the fall they discovered the temporary facility would be more difficult to construct than they imagined.
“By October, it became apparent that the space allocated for the temporary clinical trial material facility would not meet GMP requirements without allocating significantly more of the $44 million budget to these temporary upgrades,” said the NRC’S spokesperson Nic Defalco.
Vaccine production facilities have to meet exacting standards, called Good Manufacturing Practices (GMP). In the pharmaceutical industry, the standards are designed to ensure that batch to batch, vaccines and drugs are consistent and free of any contamination.
Defalco said the space for the temporary facility had structural issues that could not easily be overcome. Defalco said in addition to the added expense building out the temporary facility would have taken the same amount of time as the permanent one, so they decided to abandon the temporary facility.
The facility was designed with clinical trials in mind, where researchers often need tens of thousands of doses all produced to the same standards to show their product is safe and effective.
The Cansino deal fell apart in August when Chinese customs authorities refused to send samples of the company’s vaccine to Canada to allow for clinical trials.
Astrazeneca, another leading vaccine candidate, uses similar technology as CanSino. The company’s vaccine developed in partnership with Oxford University is now undergoing more clinical trials,
but early results show the vaccine is as much as 90 per cent effective.
The two leading candidates from Pfizer and Moderna both use another technology called MRNA for their vaccines. There is no capacity in Canada to manufacture such vaccines and the National Research Council won’t be able to make them even after the upgrades to the facility are complete.
Defalco said they continued work on the temporary facility even after the Cansino deal collapsed as an insurance policy, but in October, after the rising expenses came to light, the NRC felt it was best not to build a temporary facility, but to concentrate on the permanent one.
“As the NRC was no longer participating in the intended clinical trials, and as there was no product immediately available to produce in the temporary facility, the decision was made to pivot all of the resources to creating the permanent Gmp-compliant clinical trial material facility elsewhere in the existing building,” he said.