Mill Creek Beacon - Your Hometown News Source

The emergency use of a new COVID-19 vaccine has begun in Snohomish County as health officials remind the public that the virus is still spreading.

The process begins with health care workers, first responders and people in long-term care, all chosen according to risk-levels and community benefit due to limited supplies as the process begins. If all goes as planned, officials estimate the vaccination process will eventually fan out to the general public in the coming months.

Health officials estimate are six to eight months before the vaccine – or vaccines – are fully distributed and possibly longer before community protection to the level of a pandemic-end is achieved.

The FDA approval on Dec. 11 allows for emergency use of the mRNA vaccine by Pfizer-BioNTech COVID-19 that is in-use in both Canada and the United Kingdom. The Pfizer vaccine is cleared for a distribution plan throughout the US.

Another mRNA vaccine by Moderna, also intended to prevent COVID-19, was approved today, Dec. 18. Reports predicted approval Dec. 18 for the same "emergency use" category as the Pfizer vaccine, by Modern. By dinner time on the West Coast, that prediction came true.

Emergency use is not an official FDA approval, and the vaccines are still new.

But Dr. Chris Spitters, Health Officer for the Snohomish County Health District, said "the regulatory aspect of their approval is not new at all. The speed of the vaccine development process may have made some people worried. But there were multiple layers of safety and quality assurance."

In the weekly Joint Information Commission meeting Dec. 15, Spitters described a safety review process that is thorough.

Reviews included the same protocols used for oversight of other vaccines involving the FDA and the Centers for Disease and Control and Prevention.

"Those were both led by panels of independent experts in the field, and the panels found the vaccine safe and effective for use, and are recommending its use for virtually all the population."

An additional scientific safety review panel was conducted with a multi-state group, "for an additional layer of scrutiny and expert review," he said. That group agreed that use of the vaccine was a good policy choice, due to what testing has shown.

"In the clinical trials of over 40,000 recipients for the currently released Pfizer vaccine, no high grade side effects leading to hospitalization or death occurred incidence of other serious health problems was the same in the vaccine and the placebo," Spitters said.

Safety will continue to be monitored as the vaccine is rolled out, he said, in order to provide additional information on "ongoing safety of the vaccine, and to detect any rare side effects that the large but not enormous clinical trials found."

The risk-benefit analysis always used in medical treatments is weighed against a virus that can be highly dangerous to some populations: older than 60, or with underlying health conditions such as heart and lung disease, and immunity issues. Most people recover without medical treatment, but those with serious illness can decline rapidly and require breathing assistance, in a hospital setting.

Pfizer rollout in process

The county has been poised to begin and already conducted a mock delivery, to work out any problems in advance. Specific sites were not disclosed by the JIC, due to security concerns, he said.

Meanwhile spread of the virus continues. Two-thirds of infections in the county from close contacts and community interactions, which includes homes and workplaces.

The current count as of Dec. 17 is 18,939 cases in the county and 349 deaths; 94 people are hospitalized and 18 require ventilators.

Doctors in past interviews have said a full end to the pandemic will come with a comprehensive approach of prevention and therapy. Prevention available now includes masking, social distancing and vigilant sanitation. The vaccine is another prevention-tool. Therapies such as remdesivir and monoclonal antibodies are used in the hospital setting for severe illness, and data is collected to judge their benefits.

The vaccine is not expected to help those who already have the virus. "There's some light at the end of this tunnel and just really excited about that. We know a lot of people have been looking forward to this day – knowing that effective vaccines are the best way to end a pandemic – it's just great news," Somers said, reminding all that patience is needed. "It will take well into next year before everybody" who wants the vaccine can get it.

And vaccination will not immediately end the need for masks and other precautions, he said.

"We will have to continue to wear masks and maintain physical distancing protocols. While the vaccine does protect yourself to a great degree, it does not necessarily mean you can't transmit the virus to others," Somers said.

New science

Spitters was asked by the Beacon during the most recent JIC update if the data for the current vaccine showed any therapeutic benefit. Some vaccines provide both prevention and therapy. He said data shows that the first vaccine by Pfitzer and BioNTech is not expected to help people who are already sick.

"The vaccine has not been studied as a therapeutic vaccine to treat COVID disease. Its design, intent and the evidence base for it is to prevent COVID disease," Spitters said.

All treatments come with risks.

While mRNA vaccines are new science, the data so far is promising. Pfizer's fact sheet says "approximately 20,000 individuals 16 years of age and older have received at least 1 dose of the Pfizer-BioNTech COVID-19 Vaccine," and a second dose is needed within three weeks.

"There certainly are common mild side effects, pain, swelling, redness at the injection site, sometimes tiredness, fever, achiness, especially after the second dose four weeks later," Spitters said. "But no serious adverse effects. So that's what the trials were measuring."

The mRNA vaccine is a new method to promote immunity. Vaccines often use a weakened germ to trigger immune response. Flu vaccines work that way – training the body to fight a germ by introducing a less damaging version of the illness. The mRNA vaccines show the cells how to make a protein that triggers immune response, without introducing the germ itself, according to the CDC.

"That immune response, which produces antibodies, is what protects us from getting infected if the real virus enters our bodies," the CDC states.

Two vaccines approved for emergency use under the FDA – Pfizer and Moderna – are vaccines that are based on a injection of a chemical that's called messenger RNA, Spitters said.

Spitters described the process in the JIC event:

The mRNA vaccines are a sequence of messages strung together like a chain, and that string is made in nature. When our genes are trying to run the cell and make proteins, the genes generate. The gene is read, and then a string of messenger RNA is made from the gene that gives the instructions for making proteins; then that chemical goes out of the nucleus of the cell – the center of the cell where the genes are located – and travels out into the other part of the cell where the machinery picks up that long string, reads it, and makes a protein.

"That's what happens in nature," he continued.

With the mRNA vaccine, what happens is we inject that string – that message – into the arm: it's picked up by the cells of the body. They then read the machinery in the cell – reads that just like it does the messages that we make from our own genes and ... it makes this protein that is part of the virus' outer shell, into which we develop an immune response that is protected. So what we're doing is inserting a message into our body that our body reads, makes a protein that is not ours, and then we develop a reaction to that, and a memory of that reaction in case we ever see that protein again on the virus – if we get exposed to it, Spitters said.

"After the the cell machinery is done reading it and making protein from it, then it is broken down and eliminated from the body. So no there's no change in the DNA, and we don't – there's no chip, or microchip, or anything like that in there," Spitters said, apparently addressing a rumor on the workings of the new vaccine.

Once complete, the cell "breaks down gets rid of the mRNA, and that's it," he said.

The vaccine cannot give a person COVID-19, he said. If someone got side effects from the shot, the "difference is it resolves after one to two days, and it doesn't include any of the other symptoms of COVID like losing your sense of smell or getting congestion, or having a cough or difficulty breathing. It's just that kind of achy. 'I don't feel good,' headache, low-grade fever."

Check back for updates on the vaccine and other news.