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Update on COVID-19 Vaccine

Update on COVID-19 Vaccine

Nearly a year into the COVID-19 pandemic and hope is finally on the horizon! There are two vaccines currently available for distribution in the US. The vaccines, developed by Pfizer-BioNTech and Moderna, Inc. - use a new vaccine platform called mRNA (messenger ribonucleic acid, a complex compound that functions in cellular protein synthesis and replaces DNA (deoxyribonucleic acid) as a carrier of genetic codes in some viruses).

According to the CDC, "COVID-19 mRNA vaccines give instructions for our cells to make a harmless piece of what is called the 'spike protein.' The spike protein is found on the surface of the virus that causes COVID-19. COVID-19 mRNA vaccines are given in the upper arm muscle. Once the instructions (mRNA) are inside the muscle cells, the cells use them to make the protein piece. After the protein piece is made, the cell breaks down the instructions and gets rid of them. Next, the cell displays the protein piece on its surface. Our immune systems recognize that the protein doesn't belong there and begin building an immune response and making antibodies, like what happens in natural infection against COVID-19. At the end of the process, our bodies have learned how to protect against future infection."

Both vaccines are about 95% effective against the virus and both require two doses about a month apart. It’s been reported that about half of people receiving the vaccine will experience modest side effects, including fever, headache, fatigue and pain at the injection site. Research has shown about 60% immunity after the first dose and up to 95% after the second dose. Also, it looks like immunity kicks in very soon after the shots. Despite the partial immunity, experts say people must get the second dose for full immunity.  

Experts, including Dr. Anna Wald, UW Medicine Professor of Allergy and Infectious Diseases and COVID vaccine trial lead, are hoping that immunity from the vaccine will be longer lasting than natural immunity, which, like other coronaviruses and the influenza virus, does not last long-term.  

In terms of safety, though the process has been expedited, safety protocols have been rigorously adhered to. Certain steps in the development have overlapped, saving precious time in the process. Clinical trials, historically, have gone entirely through animal studies, Phases I, II and III – which means written up, published, assessed and reviewed by peers – before the next stage would begin. And during the entire process, an independent monitoring board follows developments and can tell within a few months if there will be major concerns. But with the COVID-19 vaccine trials, as soon as researchers found no safety concerns, they began the next phase. So far, nothing has come up to suggest a serious safety problem.

Because of rigorous FDA processes, vaccine trials have been known to take up to a decade. The medical community is looking forward to using this new template for "emerging pathogens of great public health priority, and others that we've desperately been trying to make," says Dr. Julie McElrath of the Fred Hutchinson Cancer Research Center.

On December 11, the FDA approved the emergency use authorization for the Pfizer-BioNTech vaccine. With input from the Department of Health, the FDA found the vaccine safe, effective, and ready for use. Washington joined Oregon, California, Nevada, and Colorado in the Scientific Safety Review Workgroup, a panel that was created as an additional checkpoint in the process because these vaccines have come to market so quickly. As a result, on December 15, Washington State was ready to confidently distribute the vaccine to critical populations.

Washington uses a framework for equitably distributing the vaccine based on the National Academies of Medicine guidelines. In addition, the state gathered input from expert groups and community partners about who should receive the vaccine first. Though the framework continues to evolve, those first in line for vaccination are high-risk healthcare workers, such as emergency room professionals. Also, first responders, who may also come in close contact with people exposed to COVID-19 and residents of long-term care facilities will receive the vaccine first.

Other critical populations include people with certain pre-existing medical conditions that put them at high risk for complications from COVID-19, for example, people with suppressed immune systems. These populations will likely receive the vaccine in the next wave and be identified and notified through heath care networks. Washington received 60,000 doses initially, with more arriving every week. Vaccination will be free, according to the CDC, although administrators may charge a fee for delivering it.

Both the Pfizer-BioNTech and Moderna vaccines require refrigeration, Pfizer's at -70 degrees Celsius, and Moderna's at -20 degrees. For the Pfizer-BioNTech vaccine, this presented some distribution concerns. However, the company has "designed its own packaging to keep doses super cold with dry ice, so that they can be stored for a few weeks without specialized freezers," according to NPR.

Vaccine development is a complicated business and there will always be more questions. Below is a list of questions the scientific community receives frequently.

Q: When can we go back to normal? 

A: There are many variables to consider. If efficacy remains high, if immunity is long-lasting, and if people get the vaccines, we should have more clarity in six to nine months, but it could take another year. We will still have to maintain social distancing and wear masks for the foreseeable future. “Can we stop wearing masks? The answer is no, at least with the information we have now," says Dr. Santiago Neme, Medical Director at UW Medicine Northwest Campus and infectious disease expert.

Q: What if I had COVID-19? Do I get the vaccine?

A: "It's still too early in the pandemic to know if natural infection is going to afford protective immunity," says Dr. McElrath. Dr. Wald adds: "Right now the recommendation is to get the vaccine if you have not had symptomatic COVID in the past three months. I should add that… there is no safety concern in that group."

Q: Do I need to quarantine if I'm exposed to COVID after I have been vaccinated?

A: "The current status is that all policies that are currently in place will continue to be in place and followed for the foreseeable future," says Dr. John Lynch, head of UW Medicine’s Infection Prevention Group. So yes, you will need to quarantine.

Q: Does it matter what vaccine I take?

A: At this point, no, but when you get the vaccine, you must take the same vaccine for both doses. They  are not interchangeable.

Q: Will we have to do annual COVID-19 vaccines?

A: We don't know that yet. We have to see what the durability of the immunity is from the vaccines. We also have to learn more about how the virus might be changing in the population.

Q: What about these side effects I've heard about?

A: The most common side effects will be low fever, body aches, and injection site pain, and usually last no more than two days. Very rarely, recipients have shown symptoms of Bell's palsy, a generally temporary condition that affects facial muscles, and anaphylaxis. Researchers are looking into what may cause this.

Q: How will I be able to tell if I have antibodies because of COVID or antibodies from the vaccine?

A: After you receive the vaccine you will have antibodies in your blood. However, the COVID tests we are using do not measure this new vaccine generated antibody. So you should not test positive on a COVID test despite having antibodies from the vaccine.

Q: Are there other vaccines coming?

A: There are two other vaccine strategies being developed in the United States. One uses genetically engineered viruses called adenoviral vectors. The engineered viruses are designed to shuttle a gene from the novel coronavirus into our bodies where our cells will read it and make coronavirus spike proteins. Those self-made spike proteins would train our bodies to detect and terminate any real COVID-19 infections before the virus wreaks havoc.

The other approach is called recombinant protein vaccine. With this approach, a vaccine is produced through recombinant DNA technology which enables DNA from two or more sources to be combined. This involves inserting coronavirus DNA into an antigen, such as a bacterial surface protein, which then stimulates an immune response in our bodies similar to the adenoviral vector method.

Protecting everyone protects you. This is what we have to remember as we continue to deal with uncertainties. It seems likely that COVID-19 will remain a big concern for another year, so please continue to wear masks, limit gatherings, distance yourself socially, and get a vaccine once it's available to you.

Further sources on information on COVID-19 vaccines:

NIH.gov

CDC.gov

https://www.doh.wa.gov/emergencies/COVID19