Here’s what you need to know about the new Moderna COVID bivalent vaccine
In what is being hailed as a big step forward in the COVID-19 vaccination campaign - if not a new tool in the tool box, then a better-sharpened tool," as one senior expert put it - a new dose that targets Omicron is expected to land in Canada in the coming days.
On Thursday, Health Canada officially authorized Moderna's new bivalent vaccine for adults, becoming one of the initial countries to green-light the first of an anticipated new generation of mRNA vaccines that have been updated to try to keep pace with COVID's emerging variants.
Omicron was really a game-changer," Dr. Supriya Sharma, Health Canada's chief medical adviser, told media.
It changed the way that people's immunity is expected to last and the durability of it, but in response to that, we do have vaccines that we can adapt and that we can update."
The new shots are essentially two vaccines in one, experts say: part the original vaccine dose, part new formula that was designed to be more effective against the original Omicron strain, also known as BA. 1. They're designed to be given as a booster shot. The hope, experts say, is that the new shots will bolster waning protection ahead of a possible fall wave.
Here's what you need to know about the new shots.
When will they get here?
Right away, says federal Health Minister Jean-Yves Duclos.
On Friday, 780,000 vaccines will arrive in the country, and a total of 10.5 million will arrive in the next few weeks," he told media.
Like previous waves of the vaccination campaign, the doses will be sent to the provinces and territories, and it will be up to local health authorities to distribute them and to decide who gets them.
Ontario's health minister says the province expects to receive its first delivery next week.
Who is eligible?
While the final decision on availability will be made by the provinces and territories, the National Advisory Committee on Immunization is recommending that anyone over 18 who is getting a fall booster get a bivalent one, if possible. The committee adds that adults should get a normal mRNA shot if a bivalent dose isn't available.
The panel of experts also says that anyone age 12 to 17 who is at particularly high risk for COVID could be offered one, though this use would be what's called off-label, as Health Canada hasn't authorized it for that age group yet.
Does that mean I can have one now?
Like the first round of vaccines, some jurisdictions are making the first shots available only to those at high risk. In Ontario, the health minister said the first available doses will go to residents and staff at long-term-care homes.
However, the federal health minister said there will be enough arriving for every adult to have one this fall and winter.
Just how many has Canada bought?
Canada has ordered a bunch. Last month, Moderna announced it had a plan to supply 12 million doses of the shot to Canada. The federal government had exercised rights established in earlier contracts to buy an additional 2.5 million doses and moved up to this year a booster shipment of 1.5 million shots planned for 2023.
We thank the Government of Canada for their trust in our mRNA technology and our next-generation bivalent COVID-19 vaccine platform," company CEO Stephane Bancel said in a release at the time. As we have seen throughout this pandemic, the Government of Canada continues to take important steps in preparing for the winter season and protecting its people against Omicron."
Someone on social media says it was only tested on eight mice? Is that true?
No. That's misinformation that seems to stem from confusion around some of the early data provided to the American FDA about a different booster targeted at Omicron BA4 and 5.
The Americans changed their system so that they could authorize the new shots just based on animal data - advocates of the change argued we know enough about the vaccines that full human studies weren't neccessary. But that's talking about a different booster, and Health Canada still cited human data in its authorization of its own, different booster.
How was the vaccine tested?
Because the booster shot is very similar to the original Moderna vaccine, it wasn't required to clear large-scale trials a second time, but the new version was still compared to the original and found to have a similar safety profile and side-effects, Health Canada says.
In a trial of 814 adults, slightly more than half were given the bivalent and the rest were given the original Moderna dose, and the immune response of both were compared.
The results presented indicate that the new Spikevax BivalentTM vaccine induces similar responses to the Original virus and significantly higher responses to the Omicron BA. 1 virus when compared to the SpikevaxTM Original approved vaccine," Health Canada said.
Why wasn't this one tested on thousands of people like the previous vaccines?
Because this vaccine is so similar to the original Moderna shot it didn't have to undergo all the testing that a brand new vaccine would. It's kind of like the flu shot, which is updated every year to target new strains but is still essentially the same vaccine.
How well does the bivalent booster work?
According to Health Canada, the new vaccine prompts your body to guard against the original virus as well as the original vaccine does, though it's better against Omicron BA.1. There's also some data that suggests it's more effective against the newer strains of Omicron, such as BA4/5, though scientists are continuing to look at that.
Did that study show side-effects?
Volunteers in the study were followed for six weeks after getting the booster, and researchers will continue to report data to Health Canada at three and six months.
So far, the side-effects for the group that got the bivalent and those that got the original Moderna shot were similar, with the most common being pain at the injection site, swelling, fatigue, headache and chills.
No new safety concerns were found, Health Canada says. There were no deaths or serious adverse events, including myocarditis or pericarditis.
What if I've just had a booster or a COVID infection? Then what?
The usual recommendation is that adults should wait at least six months after their last vaccine or COVID infection, according to Dr. Howard Njoo, Canada's deputy chief public health officer.
However, he adds that regional health-care officials may shorten that to as little as three months, depending on the local circumstances.
What if I can't find a bivalent and I'm due for a booster?
While the bivalent vaccines are preferred for boosters, the original mRNAs are also still effective as boosters, according to the advice from NACI. Some of this will depend on eventual supply.
Why does the U.S. have a different booster? Is it better?
Back in the spring, the American Food and Drug Administration asked vaccine makers to start work on a booster that was targeted to the newer Omicron strains that were then becoming dominant - BA.4 and 5. That country has since authorized that version.
While Canadian officials say they've asked vaccine makers to submit the paperwork to have those versions authorized for use here, it hasn't happened yet. Experts have previously told the Star that because the BA.1 booster has been in development for longer, it might be easier for governments to purchase this fall.
Dr. Theresa Tam, the country's chief public health officer, says she's confident that the booster Canada has will be effective.
The U.S. has a slightly different variety of that, but these updated, or adapted vaccines are there to provide a broadened protection against different variants," she said, pointing to early data that suggests Canada's bivalent vaccine may still be reasonably effective against BA.4 and 5, despite not being tailored toward it.
Is being fully vaccinated' still a thing?
Not really. Current evidence suggests that protection wanes over time, and so Health Canada advises that if you haven't had a shot or an infection in six months, you should look at getting a booster.
Alex Boyd is a Calgary-based reporter for the Star. Follow her on Twitter: @alex_n_boyd