Acuitas: (noun) insight, perception, sharpness.

What FDA Approval Means

Health Canada has provided full approval for BioNTech/Pfizer’s COVID-19 vaccine (COMIRNATY®) and Moderna’s vaccine now called Spikevax®. At this time, vaccines from AstraZeneca and Johnson & Johnson are authorized for Emergency Use. In the U.S., COMIRNATY® recently received full approval from the Food and Drug Administration (FDA). Both Health Canada and the FDA are responsible for protecting public health by ensuring the safety, efficacy and security of a range of products, including drugs for people.

At this time, the AstraZeneca vaccine has not yet been approved for use in the United States, but the company is expected to submit for approval later this year. It is important to note that multiple other countries, including Canada, have authorized Emergency Use of the AstraZeneca vaccine and it has been recommended by the World Health Organization.

Understanding vaccine approvals can be confusing and this can cause concerns for some. Having Health Canada and the FDA provide full approval for COMIRNATY®, which uses Acuitas’ patented lipid nanoparticle delivery system, is an important step and one that we hope we can help to demystify through this post.

The Federal Government provides a good explanation of the Health Canada review and approval process for vaccines here.

Clinical studies demonstrated that the COMIRNATY® vaccine was safe and effective before it was authorized for Emergency Use in December 2020. Widespread use of the vaccine has greatly expanded the amount of information available to regulatory agencies, confirming the safety and effectiveness of the vaccine. In addition, further information on manufacturing, product storage and stability has been collected. On the basis of all of this information, full approval has now been provided in certain countries.

An article on CBC’s website explains why full FDA approval is important. The article says that this approval “may help lift public confidence” in the vaccine. The article estimates that hundreds of millions of doses of the BioNTech/Pfizer COMIRNATY® vaccine have been given on a global level since it was first made available for Emergency Use in December 2020. It points to the fact that because of the widespread administration of the vaccine, the FDA has never before had so much evidence to judge the safety of a vaccine.

According to this article, upon announcing the full approval, acting FDA Commissioner Janet Woodcock said: “The public can be very confident that this vaccine meets the high standards for safety, effectiveness and manufacturing quality the FDA requires of an approved product. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”

Even U.S. President Joe Biden weighed in on social media, saying: “While all three COVID vaccines have met the FDA’s strict standards for emergency use, this FDA approval should give added confidence that this vaccine is safe and effective. If you’re not vaccinated yet, now is the time.”

Overall sentiment in the media and on social media – by both average people and by health care professionals with specialities in infectious diseases and other related areas – seems to point to the thought that full approval of COVID-19 vaccines may give those who are hesitant about getting a vaccine enough confidence to now do so.

British Columbia’s Provincial Health Officer, Dr. Bonnie Henry, has said that the province is now in a pandemic of the unvaccinated. The Centers for Disease Control and Prevention (CDC) in the United States echoes that statement, putting out statistics that show that 99% of the COVID-19 deaths in that country are now of unvaccinated people.

The data shows that the COVID-19 vaccines are both safe and effective and Health Canada has fully approved both the Pfizer/BioNTech vaccine and the Moderna vaccine, with the FDA fully approving the Pfizer/BioNTech vaccine. It is crucial that those who can get vaccinated do so as soon as possible, for their own health and well-being and to help stem this vicious, deadly disease that continues to cause harm in communities around the world.

As always, we encourage people to get vaccinated, to wear a mask, to maintain social distancing – especially in crowded spaces indoors – and to hand sanitize often.

If you are curious as to why the Pfizer/BioNTech, Moderna and AstraZeneca COVID-19 vaccines were renamed, Global News has a good piece explaining that here.

* The number of vaccines administered is not consistent in these articles and that is likely because as vaccines are being administered daily, it is challenging for these numbers to remain current in articles published even just days before.

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