Health Canada has approved the NOVAVAX vaccine for SARS- CO-V2. Let's talk about it.
The Novavax vaccine is a sub protein-based vaccine attached to a nanoparticle
and includes an adjuvant, which is added to the vaccine to help stimulate any immune response.
This is a more traditional approach to vaccination. There are many other protein
subunit vaccines currently available. Two of them being hepatitis B and pertussis.
In this case, the vaccine is produced initially inside a moth cell, not inside human deltoid
muscle, like the MRI and a vaccine that uses mRNA to produce the spike protein. It's important to
note that the spike proteins that are being used are not able to infect cells. They have
been modified. So they are stabilized and they are not able to cause damage to human tissue.
The Novavax vaccine works in this way: scientists placed the spike protein
into a virus that only infects insect cells. Then mass amounts of moth cells are infected. And
the spike proteins replicate after this, they are harvested. In clinical trials,
over 14,000 adults in the UK received the Novavax vaccine, two doses of five micrograms.
There was an additional trial of 30,000 people in the USA and Mexico that also occurred with
the Novavax vaccine during the alpha variant. For the purposes of this video, we will just
be focusing on the results from the UK. 27.9% of adults were 65 years of age and over ,44.6%,
had coexisting illnesses and infections were reported in 10 participants in the vaccine group.
and in 96 in the placebo group. This gave a vaccine efficacy of 89.7%.
As you can see here, the NOVAVAX vaccine was quite effective in reducing the incidence of infection.
You can see that the placebo group had a much higher incidence
of symptomatic COVID-19 in the per protocol population. Also
no hospitalizations or deaths were reported among the 10 cases that were found in the vaccine group.
There were five cases of severe infection that were reported.
All of which were in the placebo group. It's important to note that
the clinical trials occurred while the alpha variant was more prevalent.
Researchers did report that the vaccine did show excellent efficacy against the other variants.
The Novavax vaccine is a two dose vaccine with 21 days between the first and the second.
dose. An adjuvant is something that is added to the vaccine to help stimulate an immune response.
This can increase antibody titers, induce rapid immune response
and long lasting memory. It can reduce the required doses of antigen,
and it can also enhance immune responses in the elderly and in young adults.
The most common side effects from the Novavax vaccine that were reported in clinical trials
were headache, fatigue, muscle aches, pain, and tenderness at the injection site and muscle
pain for less than two days. Local events were reported. According to the degree of severity,
notably, there were no episodes of anaphylaxis reported, no evidence of vaccine associated,
enhanced COVID-19 and no events that triggered pre-specified pause rules were observed.
There were also no episodes of Guillain-Barre syndrome and no imbalance in myocarditis or
pericarditis or in vaccine induced immune thrombosis with thrombocytopenia. More severe
adverse events classified as grade four events were reported in three vaccine recipients.
Two participants reported a grade four fever over 40 degrees Celsius
one after the first dose and the other.
After the second dose, a third participant was found to have had positive results for SARS-CoV-2
on PCR at baseline. There were two deaths related to COVID-19 during the clinical trial,
one was in the vaccine group and one in the placebo group. The death in the vaccine group
occurred in a 53 year old woman in whom COVID-19 symptoms developed seven days after the first dose
conveniently, this vaccine can be stored in a regular fridge at two to eight degrees Celsius.
The vaccines do increase memory B cells CD4and CD8 cells, which shows that it can induce both
a humeral and an adaptive immunity. Novavax and the serum Institute have committed to together,
provide more than 1.1 billion doses to the COVAX facility. Co-led by the world health organization.
Additionally, a Montreal facility is set to produce NOVAVAX known as Novaxolid.
This would be the first COVID 19 vaccine to be manufactured in Canada. Studies in children,
age five to 12 are underway in Mexico and the USA. A recent press release suggested
80% efficacy at preventing symptomatic infection, mostly with the Delta variant.
But what about the Omicron variant? Novaxolid has cross reactivity versus Omicron.
Three doses seem to be better than two as the antibody response after two doses
is modest. This is great news for Canada and this is great news for many countries around
the world who have already started to approve the NOVAVAX vaccine.
This is an excellent alternative to an mRNA vaccine that can be manufactured in
Canada and given to those who are unable or unwilling to receive an MRA vaccine.