Vaccines and COVID-19
As the never-ending 2020 finally comes to a close, we thankfully are seeing the approval, introduction, and distribution of vital COVID-19 vaccines in both the U.S. and abroad. Are we finally seeing the end of this ongoing crisis that has impacted every field, every sector of the world?
The answer to this question is not as simple as it might seem. Having a safe and effective vaccine, while critical, is not a silver bullet to this crisis. This update is going to go into a little more detail on why this is the case, and expand upon the flood of vaccine information that has been released over the past few weeks.
How are the global vaccination strategies going?
Europe
In June the European Union published the Communication from the Commission to the European Parliament, the European Council, the Council and the European Investment Bank EU Strategy for COVID-19 Vaccines, which sets out a number of strategic objectives, disseminated a plan to protect at-risk populations, established a robust unified regulatory process, and followed through on evidence-based science to determine the most effective diagnostics and treatments. They also established the key overarching theme that joint action is the safest and most effective way to achieve the common goal of halting the spread of the pandemic through the supply of effective vaccines.
We have started to see the fruits of this effort in Europe. While the European Medicines Agency (EMA) has yet to approve its first COVID-19 vaccine, just recently the United Kingdom became the first Western country to deliver a broadly tested and independently reviewed vaccine to the general public. The first approved COVID-19 vaccine was developed by U.S. drugmaker Pfizer and Germany’s BioNTech. Both U.S. and EU regulators may approve it in the coming days or weeks. On the heels of the Pfizer vaccine will be the Moderna option, which is also still awaiting approval from most regulatory agencies.
Canada
Canada just approved the Pfizer vaccine. The Canadian Armed Forces and Public Health Agency of Canada will lead the charge on distribution, and have estimated that once shipments arrive, vaccinations could begin in a day or two. Canadian Health officials expect about 3 million Canadians to have access to Pfizer and Moderna vaccines in early 2021.
China and Russia
In China and Russia we are seeing two very different strategies. China has less urgency because they have been able to effectively halt the spread of the virus due to strict travel restrictions. However, they do still have multiple companies pushing towards approval of vaccines in the near future. This contrasts with Russia, which has been criticized for rushing vaccines into development without adequate testing, and has experienced manufacturing issues paired with local skepticism, but still has been able to get 100,000 people vaccinated.
The United States
In the United States, Operation Warp Speed, a Trump Administration plan to provide millions of safe and effective COVID-19 vaccines to the American public, continues to move forward. Following suit and and over a similar amount of time, President-elect Joe Biden has now vowed to administer 100 million coronavirus vaccinations and to reopen most schools during his first 100 days in office.
The Food and Drug Administration (FDA) also just recently released an analysis of the Pfizer and BioNTech vaccine, showing positive results and overall support of the companies’ bid for emergency use of its coronavirus vaccine. Quickly following Pfizer and BioNTech is the vaccine from Moderna, which just filed an application with the FDA for an emergency authorization for use of its vaccine. The FDA’s vaccine advisory panel of doctors, vaccine experts, and statisticians will soon vote on whether to recommend both of these shots for emergency use.
What do you need to know about this first vaccine, and why the delay?
This first vaccine from Pfizer and BioNTech, in the U.S. at least, will be authorized for people 16 and older. Patients’ immune response to the vaccine kicks in quickly after the first dose with roughly 88% efficacy in the week afterwards. The second of two doses bumps efficacy to more than 95% and gives what is expected to be longer lasting immunity. Specifically, the data suggests that people begin producing antibodies within 10 days, which most critically reduces the risk of severe COVID-19. However, it is also important to maintain a level of caution with any new vaccine especially if you have a history of severe allergic reactions since typical practice for the first wave of clinical trials does not include this patient population.
With all this said, even if the initial results and data show that the vaccine is safe and effective for a majority of the global population, it is important to understand that every country has its own approval process. Certain countries value some data more than others, and in the U.S. thorough independent review of safety and efficacy is especially critical to emphasize when a large portion of the country is already skeptical about any vaccine. Specifically, the FDA takes time to review raw data from drugmakers and run its own analysis of trial results. The U.K. Medicines and Healthcare products Regulatory Agency relies to a much greater extent on reports submitted by pharmaceutical companies, which can speed the process up, but also present its own set of issues. Either way the approval of both of these vaccines is likely, and the difference in days between approvals will not be the real issue.
How will vaccine shortages affect the COVID-19 crisis?
Over the coming days, weeks, and months we can expect serious global competition, consistent international demand and supply shortages delaying vaccination efforts. Both of the Pfizer and Moderna vaccines each need to be given in two doses, and both companies have signed distribution deals with many countries. It is also important to keep in mind that just delivering the doses governments have already ordered could take six months or more.
The reality is that most peoples’ best hope of getting a shot by spring or early summer may rest on vaccines that have not yet been proven to work, which is why prioritization, and distribution strategies are so important.
Thankfully, we see the EU leading the way again with a strategy that lists out prioritization, and more. While many of the EU member states have their own contracts that allow the purchase of a vaccine once its safety has been demonstrated, they also have agreed to collaborate and donate or resell their vaccine doses to other countries. Canada has also pulled together a national panel with clear guidelines for provinces and territories to follow. However, Canada is in a unique situation because they have secured enough vaccines to protect a population four times its size, the most of any country in the world.
In the U.S. President-elect Joe Biden has followed the guidance of federal experts, and recommended priority be given to front-line health workers, the elderly and then other groups at higher risk of infection, including teachers. Biden has also consistently stressed that this process of vaccinating the American public will take time, and it is critical to support the overwhelmed hospitals and tens of millions of people who have lost their health insurance. The Trump administration has been less clear, but continued to insist that most American adults can be vaccinated by May.
Other than pre-purchasing about 800 million doses from six manufacturers, including the previously mentioned amounts from Pfizer and Moderna, President Trump has attempted another strategy to compel the supply of vaccines in the United States. Contrary to what we are seeing in the rest of the world, he has implemented an executive order designed to pressure vaccine manufacturers to prioritize shipments within the U.S. over other countries until all Americans are vaccinated. While on its face this “America first” executive order would be extremely concerning, it lacks legal basis, and is largely symbolic due to the complexity of vaccine purchasing and distribution.
So what must you do as you wait for a COVID-19 vaccine?
The reality is that shortages will be a consistent issue for the foreseeable future. In response the best solution is to remain vigilant, and maintain social mitigation strategies including: washing hands often, social distancing, and wearing a mask. While this crisis seems never ending, the approval of vaccines does mark an important first step. It is just not the last step, which is why Global Liver Institute will continue working to ensure the liver health patient perspective is represented as vaccines begin to be distributed.
Patients should also stay informed about distribution plans and programs in their states and localities. As countries either establish or implement these plans to respond to shortages it is important to understand if you are within a priority group. For example in Europe, they have established priority groups as healthcare and long-term care facility workers, persons over 60 years of age, persons whose state of health makes them particularly at risk, essential workers; persons who cannot socially distance, and more disadvantaged socio-economic groups. The United States has used similar language in their initial strategy plan discussions as well. In Canada health care workers and adults over 80 will be first.
To this point, we strongly believe, and the research shows that patients with liver disease must be prioritized for COVID-19 vaccines. As we have highlighted consistently whether through our 2020 policy advocacy or COVID-19 updates, patients with liver disease are at a greater risk of health complications due to COVID-19. Thankfully we have seen some government agencies acknowledge these points. However, in the coming days it will benefit all patients with liver disease if you inquire with your primary care physician, your health plan, and/or local pharmacies. Going into 2021, self-advocacy combined with global liver health advocacy will make all the difference between patients with liver disease being at the head of the line vs. the back of the line.
