Foreign Affairs Committee on April 25th, 2022

[Garnett Genuis, Conservative, Sherwood Park—Fort Saskatchewan, AB]

Does that no-fault mechanism cover theoretically possible cases of bad faith or if misleading information is presented or information is withheld? Does it cover all possible cases of liability, or does it only cover unforeseeable negative events?

[Dr. Seth Berkley]

It is events that are severe in nature that are proposed to be related to the vaccine, although obviously one cannot always make a direct connection. It is run by a commercial insurance operation and managed by them in a way that allows a specific set of responses and therefore specific payments for severe side effects and death.

[Garnett Genuis, Conservative, Sherwood Park—Fort Saskatchewan, AB]

Just to clarify my question, though, does it indemnify companies if a company might have had certain information about side effects and that information was withheld? Would those indemnification agreements cover a hypothetical case like that?

[Dr. Seth Berkley]

I would need to check with the lawyers on what the specific agreement is, but that was not the purpose of setting this up. It was not to provide blanket protection to industry; it was to make sure that if there were, as I said, severe reactions to the vaccine, unknown reactions, there would be a compensation mechanism set up.

If that's an important issue, I could have the lawyers look at what the language was.

[Garnett Genuis, Conservative, Sherwood Park—Fort Saskatchewan, AB]

Yes, if you could, please.

Are those agreements public? Have they been released publicly? Can the particulars of those agreements be provided to the committee?

[Dr. Seth Berkley]

I'm not sure they have been provided publicly. They might be privileged documents. I can look at that as well.

[Garnett Genuis, Conservative, Sherwood Park—Fort Saskatchewan, AB]

If you could either provide them to the committee or just provide us with a written update with respect to their status, that would be great.

[The Chair, Liberal, Sven Spengemann]

Thank you very much, Mr. Genuis. We'll have to leave it there.

Go ahead, Ms. Bradford, please. You have four minutes.

[Valerie Bradford, Liberal, Kitchener South—Hespeler, ON]

I have a question for Ms. Caprani.

You mentioned that you felt that TRIPS was perhaps insufficient, that it has worked well but we need to do more. Could you please elaborate on what more we should be doing in that area?

[Lily Caprani]

UNICEF's position is that we of course want to see every action possible taken to lift any barriers to expanding manufacturing capacity. For future pandemics, if we had a more geographically diverse manufacturing base, that would be a good thing. However, as Dr. Berkley has said, lifting the TRIPS waiver wouldn't have made a difference in this pandemic, because on its own it's not enough.

With regard to expanding capacity for manufacturing vaccines, which are not the same as drugs and involve a much more complex process involving multiple components, we've been very pleased to see voluntary licensing and proactive partnership between IP holders and manufacturers. Where that has happened, it has been because of technology transfer, the sharing of know-how and voluntary licensing and proactive partnership. All those things are essential. Lifting IP rights on its own isn't enough. It wouldn't allow a manufacturer to become sufficiently expert to be able to make vaccines. As we've just heard, the Moderna example illustrates that.

It's very much worth pursuing all avenues to expanding geographic manufacturing capacity in the coming years in preparation for a future pandemic, but the priority during this pandemic has been to encourage proactive partnership, sharing of know-how, technology transfer and making sure that manufacturers that are able to produce safe and effective vaccines with appropriate regulatory oversight can do so. There are plenty of good examples of that happening without a TRIPS waiver.

[Valerie Bradford, Liberal, Kitchener South—Hespeler, ON]

Thank you for that.

Dr. Berkley, Canada has committed $580 million in support and has been a key champion of the COVAX facility. What more could we do to support the COVAX facility going forward?

[Dr. Seth Berkley]

Thank you for Canada's support. Obviously, as Lily and I have both said, finance is important. What's also important, and Lily mentioned this, is trying to make sure that in major fora such as the G7, the G20, the UN General Assembly, the World Health Assembly and so on, this still is prioritized. The challenge, as we heard from some of the parliamentarians, is there is a risk that people will say, “This is over. We're done with the virus.” I don't think the virus is done with us, and therefore we need to make sure we can look at multiple problems and emergencies at the same time and continue to have the financial support, political support and health system support that is necessary both to build a strong response now and to be better prepared for the inevitability of a future outbreak, which is an evolutionary certainty, particularly with global warming, increased population, urbanization, and so on.

[Valerie Bradford, Liberal, Kitchener South—Hespeler, ON]

Just quickly, are there any lessons that can be learned from the successes and shortcomings of COVAX to date, going forward for the next round?

[Dr. Seth Berkley]

For me, there are two lessons. One is to have contingent financing available immediately so that we can go ahead and make sure we get in the queue to purchase doses quickly.

The second is to have surge capacity. UNICEF's supply division, Gavi and all of the people initially had to work with existing staff. That was overwhelming. People did it because they knew it was the right thing to do, but we need to be better prepared to surge and respond, and to keep alive all of the lessons learned from this effort.

[Valerie Bradford, Liberal, Kitchener South—Hespeler, ON]

Thank you.

[The Chair, Liberal, Sven Spengemann]

Thank you, Ms. Bradford.

Colleagues, on our collective behalf, I'd like to thank our witnesses, Dr. Berkley and Ms. Caprani, for being with us today.

Thank you very much to our witnesses, for your expertise and, above all, your service.

Thank you so much for the important work. We'll let you disconnect now. Travel safely, both of you, and thank you again.

Colleagues, we'll go right into our next panel. I'd like to welcome, from AstraZeneca Canada, Kiersten Combs, president; and from Pfizer Canada, Fabien Paquette, vaccines lead. Each witness will have five minutes for an opening statement.

We will start with you, Ms. Combs. I will give you the floor for five minutes. Please go ahead.

[Kiersten Combs, President , AstraZeneca Canada]

Thank you very much for having me today to provide a few brief remarks about AstraZeneca's role in fighting COVID-19.

In the face of the greatest health emergency in our generation, I'm incredibly proud of the role that AstraZeneca and our employees are playing to defeat the pandemic and to positively contribute to global public health.

The pandemic has never really respected boundaries or borders. It has represented an unprecedented global health and economic challenge. Because of this, at a very early stage in the crisis, AstraZeneca joined forces with the University of Oxford to bring together their world-class expertise in vaccinology with our global development manufacturing capabilities.

From the outset of this partnership, AstraZeneca committed to providing broad and equitable access to our vaccine and to making it available at no profit through the height of the crisis. I think this reflects our commitment to meet the urgent global public health need that we felt and to support health systems and economies recovering from the global outbreak.

In recognizing the complexity of vaccine manufacturing and the critical importance of the global supply chain, AstraZeneca helped establish manufacturing capacity in 15 countries at 25 different manufacturing sites to supply the vaccine in every region of the world as quickly as possible. This required us to rely on our own manufacturing capacity and to share our know-how with more than 20 partners, each of which is now fully equipped to supply the vaccine and contribute to our total output.

In support of global efforts to guarantee rapid, fair and equitable access to vaccines for people in all countries, AstraZeneca was the first biopharmaceutical company to join the COVAX partnership. In 2021, AstraZeneca together with our global partners supplied more than 2.6 billion vaccine doses to over 180 countries across every continent, including here in Canada. Approximately two-thirds of the supply went to low- and middle-income countries. More than 300 million doses have been delivered to 130 countries through COVAX.

Since early 2020, when the true scale of the pandemic became clear, AstraZeneca has committed to helping defeat COVID-19 by harnessing and sharing our scientific knowledge and expertise to advance the development of potential medicines to prevent or treat the virus. As you know, our Vaxzevria vaccine has been a critical part of global efforts to defeat the pandemic. It received its first approval for emergency use in December 2020 and has been granted a marketing or emergency use authorization in 93 countries worldwide. That includes an emergency use listing by the WHO.

The vaccine has demonstrated efficacy against all known variants of COVID-19, including omicron. It is also effective against all severities of the disease, from asymptomatic to severe disease and hospitalization. It's generally well tolerated, according to clinical studies and real-world evidence from over 10 million patients globally. Over the course of 2021, it's estimated to have helped prevent 50 million COVID cases and five million hospitalizations and has saved more than one million lives.

Complementing our vaccine's approach, we also quickly mobilized our efforts to advance the development of Evusheld. It's a novel coronavirus-neutralizing long-acting antibody combination for the prevention and treatment of COVID-19. Evusheld is actually the first long-acting antibody combination to demonstrate benefit in both prevention and treatment of COVID-19, as well as the first antibody therapy to have shown a high level of protection against symptomatic COVID in the pre-exposure prevention setting.

While the vaccine is helping us turn the tide of this devastating pandemic, millions of people around the world—about 2% of the population—remain at risk of COVID-19 because they're unable to mount a sufficient immune response following vaccination. These are patients and other people who are immunocompromised. They include people with blood cancers or other cancers being treated with chemotherapy, people on dialysis, those taking medications after organ transplant, or those who are on immunosuppressive therapies, including medicines for multiple sclerosis or rheumatoid arthritis.

In closing, I hope I have clearly demonstrated AstraZeneca's commitment to helping defeat COVID-19 from the very beginning of the global health crisis. Our commitment has not stopped. We remain focused on providing broad and equitable access to our vaccines and our other medicines.

AstraZeneca remains steadfast in our commitment to changing the course of this pandemic and helping ensure that those countries with the least means are able to protect their populations. This is a humanitarian challenge that we have, and it demands a global united response, not just from the scientific community but also from industries, organizations, governments and, really, every person around the globe. We are committed to continuing to play our part in this public health crisis.

Thank you.

[The Chair, Liberal, Sven Spengemann]

Thank you very much, Ms. Combs, for your opening remarks.

Mr. Paquette, you have five minutes for your opening remarks.

[Fabien Paquette, Vaccines Lead, Pfizer Canada]

Thank you, Mr. Chair and members of the committee.

Good afternoon, everyone.

I'm very grateful for your invitation today to contribute to your study.

Pfizer and BioNTech have been firmly committed to equitable and affordable access to COVID‑19 vaccines for people around the world since the beginning of the pandemic.

First, we started by introducing tiered pricing. We established one tier for wealthier nations, such as Canada, where the price was benchmarked to the historical costs of the flu vaccine. Middle-income countries were asked to pay half of that price. Lower-income countries, which represent approximately 50% of the world's population, were offered a not-for-profit price.

Second, we established multiple supply pathways, such as direct supply agreements, with governments like Canada's. To date, we've delivered more than 71 million doses here in Canada. We have direct supply agreements with COVAX. In 2021, Pfizer-BioNTech shipped more than 250 million doses, which is more than 25% of the total COVAX supply, to more than 100 countries and territories. We've supported government donation programs, including one billion doses supplied to the U.S. for donations to low- and middle-income countries, as well as the African Union. We've also initiated humanitarian donations.

Third, we've deployed a reliable global manufacturing network.

As of April 17, 3.3 billion doses of the Pfizer‑BioNTech vaccine have been delivered to more than 179 countries and territories in every region of the world.

We pledged to provide two billion doses to low- and middle-income countries in 2021 and 2022. As of April 17, we've delivered more than 1.3 billion doses to 110 countries toward this pledge.

Our supply chain and manufacturing network spans four continents and includes more than 20 facilities. We are sharing our technology with numerous manufacturing partners, including Biovac in South Africa, Eurofarma in Brazil and many others. Our voluntary licensing agreements are with partners with a strong track record in quality vaccine production and with the ability to manufacture at large scale.

Increasingly, credible voices around the world are recognizing that patents or supply is not the issue. The Africa Centres for Disease Control and Prevention has paused all COVID-19 vaccine donations until the third or fourth quarter of this year, stating that the primary challenge for vaccinating the continent is no longer supply shortages but logistical challenges and vaccine hesitancy.

The WHO has reported that many countries are struggling to achieve a high uptake of COVID-19 vaccines, despite adequate supply. The African Union and COVAX have declined options to obtain vaccines as developing nations struggle to turn supplies into inoculation. India's two major COVID-19 vaccine makers have halted production of vaccines, citing a high inventory and a lack of new orders.

To achieve the goal of vaccinating the world's population, we need to focus our efforts where they matter the most. First is investing in country readiness and addressing vaccine hesitancy. The real solutions to improve vaccine access include reinforcing and maintaining health infrastructure to deliver the vaccine, supporting frontline health workers to administer the vaccine, vaccine hesitancy campaigns to increase acceptance of the vaccine, dose sharing and removing trade barriers.

These are the major pandemic issues facing the developing world.

Second, we need to continue to address trade bottlenecks. Export restrictions were a significant trade barrier at the beginning of the pandemic. While they are currently manageable, there is always the risk that they will revert.

Finally, continued innovation is of paramount importance. Many companies are collaborating together to support R and D and manufacturing, thanks to intellectual property and pro-innovation policies. Together, we continue to address COVID-19 by designing additional vaccines that target new variants.

We are conducting research for specific dosages for special populations, such as children, and creating additional formulations that will improve the storage and handling of the vaccine to make it easier to administer in less-developed countries.

The foundation of intellectual property has enabled a strong global supply network with multiple partnerships that maintain high quality standards, resulting in an industry that is now producing about 1 billion doses of COVID‑19 vaccine a month.

As you consider making recommendations to government, I encourage you to recognize that patents are not the obstacles to equity.

Thank you very much.

I look forward to your questions in English or in French.

[The Chair, Liberal, Sven Spengemann]

Thank you very much for your opening remarks, Mr. Paquette.

Colleagues, we'll go into our rounds.

I'm struggling to manage our minutes of time. We can go a little bit past. I know that's not the preference for every colleague. Some of us have commitments at one o'clock, but we could go until 1:15.

Why don't we start by doing the following? If we pare back the opening round to five minutes, that gives us some flexibility—

[Garnett Genuis, Conservative, Sherwood Park—Fort Saskatchewan, AB]

No, please. I think each party should have six minutes to start off.

[The Chair, Liberal, Sven Spengemann]

Okay. If it's the preference of the committee, if that's the consensus, we can certainly stick with that.

We do have a bit of a constraint with respect to having started a bit late.

For six minutes, Mr. Genuis, please go ahead.

[Garnett Genuis, Conservative, Sherwood Park—Fort Saskatchewan, AB]

Thank you, Mr. Chairman.

I think it's important to start off, Ms. Combs, by addressing the elephant in the room. There is declining relative demand globally for the AstraZeneca COVID-19 shot. For instance, Africa's most populous country, Nigeria, with a vaccination rate of only 6.5%, still has decided to stop taking AstraZeneca vaccine shots. I wonder if you could tell us if you would recommend the AstraZeneca COVID-19 shot to people who are close to you and under the age of 55, based on the evidence that currently exists.

[Kiersten Combs]

I very much recognize the situation that we have globally with our vaccine. It is quite prevalent here in Canada.

To answer your question directly, I would first and foremost recommend that anybody who's close to me get vaccinated and get vaccinated wherever and however they can. The science suggests that the Vaxzevria, our vaccine, with the side effects profile that it has, is safe to take. If that's the vaccine available, I would offer it to my family members.

I will say, though, that any time you take a vaccine, any time you take any medicine, there's a risk-benefit profile associated with it that is a very individual choice. That individual choice has to be made on a person-by-person basis. It's no different with a vaccine.

[Garnett Genuis, Conservative, Sherwood Park—Fort Saskatchewan, AB]

Thank you, madam.

To be very clear, though, Canada's National Advisory Committee on Immunization issued a statement over a year ago actually recommending against the use of your vaccine for adults under 55. It was related to concerns about vaccine-induced thrombocytopenia. Provinces have issued similar recommendations.

Would you recommend that people follow that public health advice and not take your vaccine in light of what public health authorities are recommending in Canada?