CONSTRUCTION PROBLEMS DELAYED PLANS FOR A CANADIAN FACILITY THAT COULD BE MAKING ONE OF THE LEADING COVID VACCINE CANDIDATES, BUT THE FACILITY ALSO HAD NO VACCINE TO PRODUCE AFTER A DEAL WITH CHINA FELL APART.
Building of NRC temp facility abandoned
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 was a temporary set-up that would allow Canada to produce the thousands of doses of vaccine to participate in a trial with Cansino. 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 NRC 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.
The NRC worked on a rabies vaccine that uses similar technology as some of the COVID vaccines under development, but Defalco said they couldn’t just flip a switch and start producing vaccines for humans.
“That vaccine was intended only for veterinary use in animals. As such, the vaccine did not require GMP compliance from Health Canada.”
John Power, a spokesperson for Industry Minister Navdeep Bains, said the government is looking to find companies who might be interested in using the NRC’S facilities, once they’re complete, but there are no details yet.
Sources speaking to the National Post on background said there have been challenges attracting companies to use the small facility in Montreal, because it can only provide a relatively small number of doses and companies believe it would be more efficient to ship vaccines to Canada rather than manufacture them in small batches here.
The government has estimated the facility could produce approximately 250,000 doses a month, but that would depend on the type of vaccine. A second facility under construction at the NRC will be able to produce millions of doses per month when it opens next July.
Power said the government explored the deal with Cansino as part of a broader plan to invest in anything that could reasonably deliver a vaccine to Canadians.
“Canadians expect us to pursue all promising options when it comes to securing access to an eventual vaccine,” he said. “In the early days of the pandemic, the Cansino candidate was among the most advanced in the world.”
Last month, Prime Minister Justin Trudeau warned Canadians to expect some delays compared to other countries because Canada doesn’t have homegrown vaccine production.
Conservative health critic Michelle Rempel Garner said the manufacturing issue should have been clear from the start and it doesn’t excuse the government from providing a real plan to vaccinate Canadians.
“The Liberals have thrown out the manufacturing capacity thing as sort of like desperate flailing to get the public and the media attention away from the more urgent question of when are we getting the vaccines.”
The House industry committee has voted to do a study on vaccine manufacturing capacity.
Rempel Garner said it is good to know what went wrong, but she also wants the government to be thinking ahead and finding a company to manufacture a vaccine at the facility.
“We need to know whether or not there are viable candidates based on similar technological platforms that could be manufactured at that facility.”
THE DECISION WAS MADE TO PIVOT ... TO CREATING THE PERMANENT ... FACILITY.