by Edwin Quinabo
The good news: the beginning to an end to the deadly pandemic is in sight as the FDA and CDC roll out the first approved COVID-19 vaccine (Pfizer/BioNtech vaccine or BNT162b2) for distribution and administering in the US.
The bad news: the virus is at its peak and will continue to infect communities with a fury. Health experts estimate some 200,000 people in the US could contract the COVID-19 before the first vaccine (others expected for approval) will be available for everyone near Spring 2021.
Social distancing, avoiding crowds, wearing a mask, washing your hands, staying away from hot spots like bars, gyms and restaurants (dine-in) – all CDC guidelines must still be followed, health officials warn. Normal Christmas holiday celebrations will have to wait until next year, as suggested earlier before the vaccine’s approval.
In the last week, COVID-19 new infections have averaged over 200,000 daily, deaths 2,200-3,200 daily, and patients treated daily for the virus at hospitals 100,000-plus. Hospitals nationwide have been operating at, over, or near capacity.
A vaccination couldn’t come sooner. Scientists responded to urgency. Now begins the largest tactical public health effort in recorded history as multi-millions of vaccines must reach multi-millions of people in the US, and eventually the rest of the world.
The FDA and CDC granted “emergency use authorization” to Pfizer/BioNtech vaccine over the weekend of Dec. 12-13, the first COVID-19 vaccine to be distributed in the US. The Moderna vaccine is expected for a vote this week and could be the second COVID-19 vaccine to get the green light.
Both the FDA and CDC found the vaccine from Pfizer and its German partner BioNtech is safe and effective based on data from their clinical trials with over 40,000 participants. Clinical trials of the Pfizer/BioNtech vaccine is over 90 percent effective.
Pfizer CEO’s Albert Bourla called the vaccine “the greatest medical advance” in the last 100 years.
The science behind how the vaccine works: Pfizer/BioNtech vaccine uses genetic material, mRNA, to trick cells into producing bits of protein that look like pieces of the virus. The immune system learns to recognize and attack those bits and, in theory, would react fast to any actual infection. The mRNA is synthetic, not extracted from actual viruses.
The vaccine went through record-breaking speed to get approval and is technically given “emergency use authorization” because Phase III of clinical trials is ongoing, expected to conclude in Aug. 2021.
Less than one day after the CDC approved the Pfizer/BioNtech vaccine, the US Operation Warp Speed project was launched as vaccines begun to be shipped and arrived at locations beginning Monday, Dec. 14.
The logistics are mind-boggling and incredibly ambitious. The US government’s Operation Warp Speed project hopes to distribute 300 million doses by Jan. 2021.
How large is that quantity?
For comparison between Sept. 2019 and Feb. 2020, 174.5 million doses of the flu vaccine were handed out in the US. Operation Warp Speed expects to double that quantity within weeks for the COVID-19 vaccine compared with the entire six months it took for last year’s distribution of the flu vaccine during flu season.
Operation Warp Speed Project plans to deliver the Pfizer/BioNtech vaccine to all 50 states the week of Dec. 14-21. Exact times are not announced for security reasons.
Gov. David Ige said the first shipments to Hawaii will be enough doses of the COVID-19 vaccine for over 80,000 people.
Dr. Elizabeth Char, director of the State Department of Health, said Hawaii will get 46,600 doses of the Pfizer vaccine and 36,000 of the Moderna vaccine and the National Institutes of Health.
Tripler Army Medical Center is expected to be the first Covid vaccine distribution site in Hawaii.
Who will be getting the vaccines first?
Each state has prioritized select populations to receive the vaccine first because of supply-logistics. Those who will be able to get the vaccine first are hospital and health care workers working on the frontlines, occupants and workers at nursing care home facilities, and first responders as recommended by the CDC. The general public is expected to start receiving vaccines in the first months of next year around April.
Char said the first in Hawaii to receive vaccinations are 35,000 frontline healthcare workers, 35,000 people living in long term care and other close-quarter settings, and first responders.
Filipino community reaction
“I have a sense of relief that a vaccine is finally available,” said Rose Cruz Chuma of Kaneohe. She said she plans to take the vaccine and will encourage the rest of her household to do the same. “Vaccines only work as a public health issue if everybody gets one — same reasons why all the kids are immunized and vaccinated at certain ages and why seniors particularly are encouraged to get pneumonia shots, flu shots.”
Health experts say in order for the virus to be controlled in communities or reach what is called herd immunity, at least 75 percent of the population must take the vaccine.
Myra Asuncion, formerly of Salt Lake now a Washington State resident where the coronavirus was a hotspot in the early Spring, said “I’m so thankful to God. The vaccine is the best Christmas gift for the world. People here have been on pins and needles. My sister works in a hospital. Near there are several nursing home facilities.
“When the virus spread in the nursing facilities and people were dying, everyone were afraid, especially health workers who didn’t have in the spring and summer adequate protective gear.
“The vaccine is a game-changer. We all must do our part and trust the science and medical professionals, get our shots. If you really think about it, getting the vaccine is a blessing. I can’t imagine why anyone would have hesitation. People are reluctant in the US right now. People in most parts of the world would be begging to get it.”
A December NPR/PBS Newshour/Marist College poll finds that 61 percent of Americans say they’ll choose to get the coronavirus vaccine when it is made available to them. Other polls earlier taken – Gallup, Pew Research Center and Quinnipiac University – show similar numbers near 60 percent.
The trend seems to show a rise in confidence. Earlier September and October polls had numbers in the 50-percentage range and below.
According to a December survey by the University of Hawaii, Hawaii residents have more reservations than the national average about taking the vaccine. Only 44 percent of Hawaii residents plan to take the coronavirus vaccine when it becomes available; 37 percent are still unsure whether they’ll take it.
Belinda Aquino, Ph.D., of Honolulu said of the vaccine, “It is a significant development. I could sense some rush or hurry to produce the vaccine. This is understandable because of the eagerness and anxiety on the part of everybody wanting a ‘magic cure’ for COVID-19. But it has to be understood by everyone as well that much research and experimentation are essential for a potential cure.
“I hope the experts have produced a number of markers regarding who should be given priority to receive the vaccine. I agree that first responders or those on the frontlines like nurses and doctors be given priority. Also, that older people with underlying symptoms should also be attended to first.”
Aquino adds, “Have some side effects been found? Can younger healthier individuals wait? As everyone knows, the Covid 19 virus is relentless, rapidly striking everywhere regardless of age, gender and other indicators of health. There are so many incomplete issues at this point. “Sometimes, people get impatient and even desperate for a ‘magic cure’ which puts pressure on experts in their pursuit of such a cure. But like any other first-time attempt to cure any disease in history, the results are unpredictable, and at best, can only assign a certain percentage (50 to 90 percent) of how effective it might be,” said Aquino.
Marilyn Cadiz of Pearl City said she is thrilled about the vaccine. “Everyone has been under a lot of stress. There is too much sadness for those who already died. We all want to get back to normalcy. When the vaccine is available to me, I’ll get it. I do understand people being afraid in the beginning. But we should remember that tens of thousands have already taken the vaccine in multiple clinical trials.”
More public education awareness needed
Aquino said, “more information should be available for people to receive and read and understand for their own safety and protection in the long run.”
Georgetown law professor Lawrence Gostin, who has previously advised the World Health Organization on vaccine planning, said “the science of education is no less important than the science of vaccine development or the science of epidemiology. It’s no good having a 95 percent effective vaccine if you don’t have at least 70 percent of the population willing and able and do get the jabs in their arm.”
Dr. Uche Blackstock, an emergency medicine physician who founded a company focused on health care equity, said “We need really expansive public health campaigns that are engaging community-based organizations and trusted leaders and Black communities.
An initial $15 million public relations campaign launched by the Trump administration had been cancelled. Another $250 public awareness campaign is in the work. But a soft campaign already started. Just last week the federal government put out a modest $150,000 ad buy on YouTube encouraging people to take the vaccine.
On skepticism to taking the vaccine, Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, said “Well, what you need to do is what we’re trying to do—is to go through the steps of how the vaccine was produced, tested, and then the evaluation was made, whether or not it was safe and effective and in each and every one of those steps where there is skepticism and concern, I think you can counter it with a real firm argument. First of all, some people say it was so quick, you just found out about this new disease in January. How could you possibly have a vaccine available to inject into people into December, which would be less than a year? And this is a good answer to that in that the process is the quickest we’ve ever done in history, but that’s the course of the extraordinary advances in the techniques of the scientific basis for the platform technology that’s used to make the vaccine.”
“Generally, the most common reaction is what you see with most, any other vaccine: a sore arm, a little bit, you might feel a little bit fatigued and down for 24 hours to 36 hours at the most; a small percentage of the people might get a fever that would last for 24 hours. You take a Tylenol, you can take care of that without much problem, with the safety of severe adverse events is really very good. And the 30,000 people in the Moderna trial and the 44,000 people in the Pfizer trial, there were really no severe adverse events.”—– Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases
Who shouldn’t take the vaccine
At the moment, much of the educational awareness has been coming from what Pfizer/BioNtech has been telling the media, mostly on who cannot take their vaccine.
There are groups who should not take the vaccine just yet (more studies need to be done in clinical trials on these groups). The following individuals should not take the vaccine:
- Anyone with a significant history of allergic reactions. (Dr. Fauci advises against taking the vaccine for this group; but some health experts say this group could get the vaccination under physician supervision with a EpiPen readily available.
- People with immune suppressed conditions (individuals with cancer, those who’ve had a transplant, people taking certain medications like corticosteroids or other medicines that suppress the immune system).
- Pregnant and breastfeeding women.
- Children under 16. COVID-19 vaccine trials for children are just beginning. Pfizer is already recruiting participants to test their COVID-19 vaccine in kids 12 years and older. Moderna has also started the process for their clinical trial.
Everyone else can take the vaccine.
Another area being stressed in the initial public awareness stage is that early vaccines (Pfizer and Moderna’s) are a two-part process.
The earliest COVID-19 vaccines being rolled out require two-parts in order for the shots to be over 90 percent effective in preventing COVID-19. The Pfizer vaccine requires people taking two doses 21 days apart; the Moderna vaccine requires 28 days apart.
The two-part process requires logistical challenges of their own. Each site that the vaccine is administered must comply with patient confidentiality, record keeping, scheduling appointments for the second required dose, and post-vaccination monitoring.
Based on the history of other vaccinations that require two-parts, it’s common that people do not go in for a second dose. Public health experts say there must be more public awareness campaigns to stress the importance of compliance in getting the second dose. Currently, there is no national electronic system to track and encourage Americans to return for a second dose.
Dr. Fauci said, “Generally, the most common reaction is what you see with most, any other vaccine: a sore arm, a little bit, you might feel a little bit fatigued and down for 24 hours to 36 hours at the most; a small percentage of the people might get a fever that would last for 24 hours. You take a Tylenol, you can take care of that without much problem, with the safety of severe adverse events is really very good. And the 30,000 people in the Moderna trial and the 44,000 people in the Pfizer trial, there were really no severe adverse events.”
If there are any health concerns for your specific health condition, it’s advised to consult your personal physician.
Stay the course, practice CDC safety guidelines
Public health officials say that while a vaccine is being distributed, everyone must still follow CDC recommended guidelines of social distancing and mask wear, especially during this critical winter surge.
On Christmas gatherings, that means celebrations should be kept to only members of your household, or 10 and under if others are invited to your gathering, but with strict social distancing and mask wear enforced.
The four top places still to avoid if possible are bars, gyms, restaurants (dine-in) and public transportation. Even as the vaccine becomes readily available to more people in time, it’s recommended that people wait for the CDC to announce when safety guidelines of social distancing and mask wear could be lifted.
Churma said until the virus is completely eradicated, she will still wear a mask in public and practice social distancing and avoid crowded areas. “Even if the virus ceases to be a public health issue, Zoom and digital meetings have taken root—this is the upside of the mandatory social distancing. Imagine all the gas we saved! All the commuter hours saved, all the make-up and fancy clothes that have become obsolete.”
Asuncion hopes that the vaccine now being available will not change how this year’s Christmas is celebrated. “Holiday gatherings, actually all indoor gatherings, are known as potentially super spreader events. It’s cold here in Washington state, in the 30s and 40s, we don’t have the luxury of having our Christmas parties in the garage or lanai like in Hawaii. We will go ahead with our earlier plan to celebrate only with those in our household.”
Aquino recommends that everyone still comply with all safety and protection measures. She believes if people don’t, there still will be “a lot of anger, hostility, and public shaming for those who disregard safety [even now that a vaccine is out].”
Cadiz is confident most people will continue safety. “If people are afraid to take the vaccination, of course it makes sense that they will be concerned about their safety and practice social distancing and wear a mask. Only the people with no courtesy and no class will drop safety measures. But these are the same people who haven’t followed safety guidelines even before the vaccine, a small percentage of people, at least here in Hawaii.”
Keep cost down
Healthcare advocates say if the goal is to beat COVID-19, the government in cooperation with pharmaceutical companies must keep the cost for the vaccine either free or as low as possible.
Right now, the vaccine is free to most Americans. Those who have insurance, could be billed, but can file a claim for reimbursement with their insurance company. It’s also possible that some places will charge around $20 for each of the two-part vaccination processes.
Step one on the road back to some normalcy begins now. Health experts say if we do our part, herd immunity could take place around the Fall, 2021. Dr. Fauci said, “I think that we’re going to have some degree of public health measures together with the vaccine for a considerable period of time. But we’ll start approaching normal — if the overwhelming majority of people take the vaccine — as we get into the third or fourth quarter [of 2021].