Moderna seeks Health Canada approval of COVID-19 vaccine for youngest children, announces new Montreal facility - The Globe and Mail

Ilana Diener holds her son, Hudson, 3, during an appointment for a Moderna COVID-19 vaccine trial in Commack, N.Y. on Nov. 30, 2021.EMMA H. TOBIN/The Associated Press

Moderna, Inc. has officially asked Health Canada to authorize its COVID-19 vaccine for children as young as six months old, making the company the first to seek Canadian approval to inoculate babies, toddlers and preschoolers against the pandemic virus.

Patricia Gauthier, Moderna’s Canadian general manager, told a news conference Friday that the company submitted its application to Health Canada Thursday night, not long after it filed for approval in the United States.

“We’re really proud to announce that we filed to Health Canada [Thursday] night our dossier to ask for the extension of the indication for a vaccine so that we could protect potentially infants as early as six months of age,” Ms. Gauthier told a Montreal audience at an event announcing plans for a Moderna vaccine plant in Quebec. “So it’s now in the hands of Health Canada.”

Many Canadian parents have been waiting eagerly to find out when the shot will be available to the youngest children. Right now, Health Canada has approved the Pfizer-BioNTech shot, sold under the brand name Comirnaty, for children as young as five, and Moderna’s shot, SpikeVax for children as young as six.

It’s too early to say how soon Health Canada will make a ruling on Moderna’s application. In the past, a few weeks to a few months have elapsed between vaccine-makers submitting their data on COVID-19 shots and the regulator granting approval.

News of Moderna’s application emerged on the same day the Massachusetts-based company fleshed out its plans for a manufacturing plant in the Montreal area that will eventually pump out shots for COVID-19 and other respiratory illnesses, along with future vaccines for whatever yet-to-emerge virus sparks the next pandemic.

On Friday, Moderna Chief Executive Officer Stéphane Bancel, Prime Minister Justin Trudeau, Quebec Premier François Legault and other politicians gathered at McGill University to announce the 10-year agreement, which also includes a Moderna commitment to spend an unspecified amount of money on scientific research in Canada.

“With this new Moderna facility Canada will now have more timely and more secure access to domestically-produced mRNA vaccines to respond in the event of future health emergencies, including future pandemics,” federal Health Minister Jean-Yves Duclos said.

Moderna and the federal government announced last August that they had signed a memorandum of understanding that would culminate in Moderna making Canada the site of its first manufacturing plant outside the United States, but the parties did not announce a location for the facility until Friday.

Moderna has since announced plans to build a plant in Australia on a similar timeline.

When the pandemic hit, Moderna was a startup with limited production capacity and no approved products. It contracted with other vaccine-makers, namely Switzerland’s Lonza, to pump out tens of millions of its mRNA shots, which alongside a similar vaccine made by Pfizer-BioNTech, helped curb the death toll of the pandemic.

Messenger RNA is a single-stranded molecule that transmits instructions for cells to manufacture proteins. In the case of the mRNA vaccines for COVID-19, the shots were encoded with a message telling cells to make the spike protein that studs SARS-CoV-2, coaxing the immune system to mount a defensive response it could repeat if the real virus showed up.

The shots were the first mRNA products to garner regulatory approval around the world.

“For the first time in the history of medicine, we have a molecule that is an information molecule and that changes everything,” Mr. Bancel, the Moderna CEO, said. “It is like going from Blockbuster to Netflix. It is a change of paradigm and we’re bringing this technology to Canada, which we’re very excited about.”

Moderna is now working on updated versions of its COVID-19 vaccine aimed at a broad range of variants, including the super-contagious Omicron, which has blunted the ability of vaccines to prevent mild infections. The mRNA vaccines still substantially reduce the risk of severe illness and death, especially in those who have received three or more doses.

Moderna has other prospective mRNA shots in its pipeline, including an mRNA flu shot scheduled to enter a phase three trial this fall, and an mRNA shot for respiratory syncytial virus, or RSV, for older adults that is already in phase three. RSV is a seasonal respiratory virus that is most dangerous to the very young and very old.

The “ultimate goal,” said Shehzad Iqbal, Moderna Canada’s medical director, is to create a single annual shot that would be effective against  multiple strains of COVID-19, influenza and RSV.

“We can create all these great vaccines, but if people don’t take them, it doesn’t help,” Dr. Iqbal said in an interview before Friday’s announcement. “If you can simplify the implementation side by combining them into one shot, then it just becomes a little bit easier to get better uptake.”

That goal is a tall order: There is currently no approved vaccine for RSV, while making a universal flu vaccine has bedevilled researchers for decades.

Along with producing vaccines against infectious respiratory diseases, the other purpose of the Moderna plant would be to supply Canada with emergency shots in the event of another pandemic.

By the time COVID-19 emerged, Canada had scant vaccine manufacturing capacity, leaving the country to rely on imported COVID-19 shots. The sector shrank over decades under multiple governments.

Canada did have a contract with the pharmaceutical giant GlaxoSmithKline to produce a pandemic flu vaccine at its plant in Quebec, but when the pandemic was caused by a coronavirus, not influenza, that contract was useless.

The mRNA platform, capable of being quickly recoded with the genetic sequence of a new virus, is more flexible than older ways of making vaccines.

The federal government has announced more than a billion dollars in investments in the biomanufacturing sector since the pandemic began, including $200-million for Resilience Biotechnology to expand its mRNA-making facility in Mississauga; $126-million for a National Research Council plant to make Novavax’s COVID-19 shot; and $415-million for Sanofi Pasteur to build a new flu vaccine facility in the Greater Toronto Area.

With files from Canadian Press

Our Morning Update and Evening Update newsletters are written by Globe editors, giving you a concise summary of the day’s most important headlines. Sign up today.

Adblock test (Why?)

https://news.google.com/__i/rss/rd/articles/CBMidWh0dHBzOi8vd3d3LnRoZWdsb2JlYW5kbWFpbC5jb20vY2FuYWRhL2FydGljbGUtbW9kZXJuYS1zZWVrcy1oZWFsdGgtY2FuYWRhLWFwcHJvdmFsLW9mLWNvdmlkLTE5LXZhY2NpbmUtZm9yLXlvdW5nZXN0L9IBAA?oc=5

2022-04-29 12:05:16Z
1381022070