COVID-19: A Consumer’s Guide to the Coronavirus

Coronavirus disease 2019, also called COVID-19, is a respiratory illness that spreads between people. It’s a novel coronavirus, which means people have no immunity to it.

Big drug companies such as Sanofi, GlaxoSmithKline and Johnson & Johnson subsidiary Janssen Pharmaceuticals are working along with several smaller companies and sponsors to develop vaccines.

Although the Food and Drug Administration has not yet approved a COVID-19 vaccine, the agency issued the first emergency use authorization for a vaccine on Dec. 11, 2020. The authorization allows the Pfizer-BioNTech COVID-19 vaccine to be distributed in the U.S. The FDA is expected to also grant an authorization for the Moderna COVID-19 vaccine.

To “flatten the curve” and slow the virus down, governments worldwide have been telling people to use social distancing — staying at least 6 feet away from others — and to stay home unless they need essentials like medical care or food.

Several states, counties and cities in the U.S. enforced voluntary and mandatory self-quarantine policies to slow the spread of the coronavirus. Pay attention to your local officials to keep up-to-date on the policies that affect your health.

Pfizer, BioNTech and Moderna have been the front-runners in the race to develop COVID-19 vaccines. The good news is that data has shown these vaccines to be effective and safe. Both companies could start shipping the first doses in December 2020, according to experts.

Moderna began working on its candidate called mRNA-1273 in January 2020. Pfizer and BioNTech began working together to develop their candidate, BNT162, in April 2020.

Both of these vaccine candidates are mRNA-based vaccines, and the companies submitted emergency use authorization, also known as EUA, applications to the FDA in November 2020. The FDA issued the authorization for Pfizer’s vaccine on Dec. 11, 2020.

“The EUA granted by the FDA brings us one step closer to being able to control this pandemic, as the EUA is a mechanism that allows products during public health emergencies to be brought to market efficiently,” Dr. Rupali J. Limaye, a professor and scientist at the Johns Hopkins Bloomberg School of Public Health told Drugwatch.

Moderna’s vaccine is likely to receive its authorization shortly after the FDA meets to review the application on Dec. 17.

At least 51 vaccine candidates have begun clinical trials and are in various stages of development, according to the Regulatory Affairs Professional Society (RAPS) vaccine tracker.

Ten of these were in Phase 3 clinical trials as of Dec. 10, 2020.

How Many Vaccine Doses Will Be Available?

In July 2020, Pfizer announced that the U.S. had bought 100 million doses of the Pfizer-BioNTech COVID-19 vaccine with the option to buy up to 500 million more doses. Each person requires two doses, which means 50 million Americans could be vaccinated with the first batch.

The U.S. government also purchased 100 million doses of Moderna’s vaccine. It also requires two doses, which means 50 million Americans could receive the vaccine. The FDA is meeting to discuss Moderna’s vaccine on Dec. 17, 2020, potentially making this vaccine available in the U.S. immediately after approval.

The government also has agreements with several other companies in various stages of vaccine development. Johnson & Johnson and AstraZeneca’s vaccines are the next two vaccines expected to be ready for use.

Dosage, Efficacy and Storage

Pfizer’s vaccine requires two doses to be effective. Patients receive the second dose 21 days after the first dose, and it has a 95 percent efficacy rate. In adults over 65, the efficacy was 94 percent. It has to be stored at -70 degrees Celsius, according to Pfizer’s distribution fact sheet.

Moderna’s vaccine requires two doses to be effective. Patients receive the second dose 28 days after the first dose, and it has a 94.5 percent efficacy rate. It has to be stored at -20 degrees Celcius, according to Moderna.

Q&A with Vaccine Expert Dr. Rapuli J. Limaye

In an interview on Dec. 8, 2020, vaccine expert Rupali J. Limaye, PhD, MPH answered Drugwatch’s questions about upcoming COVID-19 vaccines. Limaye is a professor and scientist at the Johns Hopkins Bloomberg School of Public Health and the Director of Behavioral and Implementation Science at the International Vaccine Access Center, as well as the Associate Director for Behavioral Research at the Institute for Vaccine Safety.

She provides information on how vaccines work, their importance in developing COVID-19 immunity, how they were produced so quickly and what the data shows on side effects.

What are the benefits to vaccines and why are they important in controlling the COVID-19 pandemic?

What is so great about vaccines is that they prepare your body to encounter a disease whether that’s a virus or any other kind of pathogen so that when you actually do encounter it in “real life” that you are ready to fight it. It will reduce your chances of having severe disease or death.

For us to break the pandemic, we need to have enough people that have either been a) exposed — meaning they’ve gotten COVID already — or b) get the vaccine because the whole point of a virus is that it wants to replicate. To replicate, it has to have a susceptible host. So if there are no susceptible hosts, meaning if you’ve been exposed or if you get the vaccine, then the virus will not be able to live.

There are some estimates, and they’ve changed over time, but my understanding is at least 80 percent of the population will need to have immunity to coronavirus for us to break the pandemic.

How is this vaccine approval process different from the usual process of approving a vaccine?

The good news is that the vaccine approval process is quite rigorous and systematic in the U.S. So regardless of whether or not it goes through a process that is not an emergency use authorization, which is what the COVID-19 vaccines are being governed under, it still follows a very systematic process where it goes through Phase 1 to Phase 2 to Phase 3 to Phase 4.

We are able to expedite the process because we know that people are being hospitalized. We know the severity. We know that people are dying. And that is the reason that we are able to expedite this process through an emergency use authorization. It’s to get it to the market so we can start to mitigate some of that severity and death.

Should people be concerned about the speed at which the vaccines are being developed with an emergency use authorization?

None of the [safety and review] steps are cut. It’s just that they are overlapping so that we can move the process through more quickly.

A lot of folks that work on the development of these different drugs, they are people just like you and I. And so this isn’t sort of a separate group of people that are detached from all the other concerns that we are having, like “Can my child go back to school?” You know? “When am I allowed to go to the grocery store again?” Whatever the concern may be, they are the exact same people that live in our communities.

It’s pretty incredible that people have really prioritized this and understand the importance that we need to get this out quickly. Vaccines in general don’t make money for pharmaceutical companies, and [they have probably spent] billions upon billions in developing this.

How do mRNA vaccines like Pfizer and Moderna’s vaccines work?

Essentially, it codes something called a spike protein. That’s how an mRNA vaccine is used. Then it enters your body so your body can recognize it.

It trains your immune system to recognize that this is not something that is supposed to be in your body. Therefore when it does recognize the virus for real, it is able to quickly mobilize and activate.

What do you know about the initial plans to start getting people vaccinated?

CDC has recommended health care workers and people in long-term care facilities get the vaccine first. Soon thereafter, they are thinking about other populations that live in close-quarter-type settings — for example, incarcerated populations. Prisons are really dealing with these outbreaks of COVID, and they would be high up on the list.

Any sort of housing areas where there’s a lot of people living together would be the next priority and older people above the age of 65 and those that might have a condition that makes them immunocompromised.

People that don’t have any elevated risk would be in the last tier.

The CDC can provide recommendations, however, they are not really “in charge” of deciding who gets it and when. That’s a state-level decision.

What do you recommend people do until they get vaccinated and after?

We still want people to wear face masks and social distance because we need to reach that herd immunity before we can go back to living sort of our “more normal lives.”

Even if you have a vaccine, you still need to continue to social distance and wear a face mask. Because there are varying levels of duration of immunity with vaccines and a certain proportion of the population has to have immunity for us to break the pandemic.

What type of vaccine side effects have you seen in the data?

We’ve heard that in some of the clinical trials that people might feel unwell for a couple of days. Other individuals might get a low fever. But in the context of vaccines, the side effects that we are seeing so far from the clinical trial data are very in range of normal. Most of the things people experience are not cause for concern.

Again, with that being said, if you have a question about side effects, talk to someone that understands the science so that you aren’t scared, like a vaccine scientist or doctor. I think the issue that we are dealing with is that a lot of people are turning to social media, and there’s a lot of misinformation.

It’s totally okay to have questions. We live in a weird time. It’s a novel virus and it’s a new vaccine, people are going to have questions.

I would encourage people who are experiencing side effects to call their doctor and say, “Should I be worried about this? What are the things I need to look out for?” Your doctor should be able to inform you if the side effects are something you need to go back to the doctor for.

Vaccine Resources

It’s more important now than ever to rely on only trustworthy sources of information, especially for vaccine-related content. We’ve curated the following list of reliable COVID-19 vaccine resources to help answer any additional questions you may have.

• U.S. Food and Drug Administration Coronavirus Disease 2019 (COVID-19)
• Centers for Disease Control and Prevention Coronavirus Disease 2019 (COVID-19)
• USA Today op-ed from Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration
• Moderna’s Phase 3 vaccine results
• Pfizer’s Phase 3 vaccine results
• Pfizer’s COVID-19 Vaccine U.S. Distribution Fact Sheet
• U.S. Department of Health and Human Services Operation Warp Speed Fact Sheet

Currently, there is only one medication approved to treat COVID-19: Veklury (remdesivir). Medical providers are also treating patients with supportive care such as ventilator support and oxygen when needed. Scientists are continuing to investigate other potential drug treatments.

As of June 16, 2020, the FDA revoked the emergency use authorizations for hydroxychloroquine and chloroquine. This means they should no longer be used to treat COVID-19 except in a clinical trial.

Remdesivir

Remdesivir is an intravenous drug that stops viruses from replicating and has shown potential against SARS-CoV-2, the virus responsible for COVID-19, and other related betacoronaviruses.

The FDA approved the drug in October 2020 “for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization.”

Remdesivir side effects include elevated liver enzymes which could indicate liver damage and infusion-related reactions. These reactions include nausea, low blood pressure, vomiting, shivering and sweating.

President Trump’s Experimental Treatments

On Oct. 2, 2020, President Donald J. Trump tested positive for COVID-19 and received experimental treatment with medicines and supplements including remdesivir, an antibody cocktail from Regeneron, dexamethasone, vitamin D, a daily aspirin, zinc, melatonin and famotidine.

The FDA has not approved the regimen the President received to treat COVID-19. No one should try these treatments without a medical provider’s approval.

Regeneron’s cocktail, REGN-COV2, is a combination of two monoclonal antibodies. It reduced viral load and time to alleviate symptoms in COVID-19 patients, according to a company statement on Sept. 29, 2020. The company has not released information about specific side effects, though it has said the drug is “well-tolerated.”

Dexamethasone is a corticosteroid in the same family as prednisone that relieves inflammation. Its side effects include stomach irritation, depression, anxiety, easy bruising, insomnia, vomiting and headache.

Famotidine is an antacid H2 blocker in the same drug family as Zantac (ranitidine). It’s used to treat GERD, heartburn and other conditions caused by too much stomach acid. Side effects include headache, dizziness, diarrhea, and constipation.

According to the FDA, two types of COVID-19 tests exist: diagnostic tests and antibody tests. Diagnostic tests show if you have an active infection, while antibody tests show if you have had the virus and fought it off.

Diagnostic tests are either molecular or antigen-based. Molecular tests take longer to show results, usually a day or up to a week, but they are more accurate. Antigen tests work in one hour or less, but there is a chance that the tests will miss an active infection.

Both molecular and antigen tests use a nasal or throat swab. In some instances, a patient may give a saliva sample by spitting into a tube rather than having a swab.

Antibody tests use a finger prick or blood draw, and the results are available the same day or within one to three days.

Most tests require you to go to a designated testing facility, doctor’s office or clinic, but at-home tests are also available. A health care provider prescribes the test, and the patient can collect his or her own sample and send it directly to a lab.

When Should You Seek Treatment or Get Tested?

For most people, the illness is mild, and they are able to recover at home, according to the CDC.

People who develop emergency warning signs should seek medical attention immediately. These include:

• Difficulty breathing
• Pressure or persistent pain in the chest
• New inability to arouse or signs of confusion
• Signs of low oxygen levels, such as bluish face or lips

*This is not an all-inclusive list. Consult a doctor or other health care provider for any other severe or concerning symptoms.

State, local health departments and health care providers make the decisions for COVID-19 testing. There may not be enough tests available, though they are increasing. If you have symptoms and want to be tested, contact your local health department or medical provider.

In addition to health concerns, stay-at-home orders, business closures and job loss are affecting people’s daily lives and changing the way they access medication, their medical providers and their insurance coverage.

Doctors’ Appointments and Hospital Visits

On March 18, 2020, the Centers for Medicare and Medicaid Services recommended that all elective surgeries and nonessential medical, surgical and dental procedures be postponed during the COVID-19 pandemic.

On April 19, 2020, CMS released guidelines for resuming elective surgeries. Before a state or regional hospital or surgery facility can resume non-emergency surgery, there has to be a sustained reduction of new COVID-19 cases in the general area for at least 14 days, according to a joint statement by American College of Surgeons and other professional surgical associations.

As of May 18, 2020, many doctor’s offices had been slowly reopening. Check with your primary care doctor or specialist to see if they have resumed seeing patients for regular office visits. If you had to postpone your surgery, check with your surgeon’s office to see if you can reschedule.

Consumer Tips for Medical Appointments

• If you have cold or flu-like symptoms, call your provider or nearest urgent care facility for advice.
• If you have urgent symptoms, call 911 or get to a hospital immediately.
• Reschedule appointments that are not urgent.
• Ask your medical provider to refill prescriptions over the phone or electronically.
• Ask if your provider can speak to you on the phone, online or through videoconferencing.

In addition to new medical office protocols, hospitals have also tightened their visitation protocols. Hospitals may not allow visitors, especially if the visitor has cold or flu-like symptoms. Before going to the hospital to visit a patient, call the hospital to find out its procedures.

Telemedicine Visits

For people who are at high risk of infection or who live with people who are high risk, using telemedicine might be a better option for non-emergency doctor’s appointments.

Telemedicine includes talking to a provider online, over the phone or using a special patient portal. Patient portals are a secure and private way to access your medical provider, or another medical provider, while staying at home.

Check with your medical provider, health insurance provider or employer to see if they have a telemedicine program.

Health Insurance Changes

Many health insurers are waiving copays and out-of-pocket costs associated with COVID-19 testing and care, according to America’s Health Insurance Plans. They are also waiving copays for telehealth visits with providers.

Some people may have lost their insurance coverage because of layoffs or had previously elected not to get coverage through their employers.

Health insurers may open special enrollment periods for anyone who may have declined insurance through their employers during the regular enrollment period. People should ask their company’s human resources department for more information.

If you lost your job and your health care coverage, it is a “qualifying life event,” which means you may be eligible to enroll for coverage through the Affordable Care Act’s Special Enrollment Period or through your state’s health insurance exchange.

Prescription Drug Refills

During a pandemic, getting access to medications may be more difficult than normal, especially when staying at home to avoid infection. The CDC recommends having an emergency supply of an extra 30 days of medication on hand.

But in the case of the COVID-19 pandemic, people may need a longer supply — especially if they are chronically ill or at increased risk of infection. During the coronavirus outbreak, pharmacies and health insurers are extending many 30-day prescription refills to 90-day refills.

Many pharmacies such as Walgreens and CVS offer free home delivery of prescriptions. Mail-order pharmacies are also a good option. Customers can purchase drugs online from reputable pharmacies and have the medication delivered.

Local, independent pharmacies may also be able to deliver medications for free.

The pandemic has also interrupted drug supply chains, leading to shortages of some drugs and medical devices. In addition, some drugs are in shortage because they may be useful for fighting the coronavirus. For example, hydroxychloroquine sulfate is a malaria and lupus drug that had been explored as a possible treatment for COVID-19 and was placed on the shortage list on March 31, 2020.

The FDA has posted a list of drugs that may be affected on its Drug Shortages webpage. People who find their drug on this list may contact their medical provider to find an alternative.

The regulatory agency also published recommended steps for manufacturing personnel to follow to reduce the risk of exposure to SARS-CoV-2, the virus that causes COVID-19.

Medical Device Shortages

According to the FDA’s report on medical device supply shortages from March 28, 2020, medical devices affected by shortages included N95 respirator masks, ventilators, ventilator accessories and other respiratory devices.

The agency has issued guidance to help increase the number of these devices. This includes using devices modified for use as ventilators such as anesthesia gas machines.

Between lockdowns and reduced mobility, constantly watching the news, worrying about loved ones and coping with the fear of running out of essentials, a pandemic can really take a toll on people’s mental health.

Stacy O’Mara, a licensed mental health counselor and psychotherapist in Florida told Drugwatch she has seen an uptick in people reaching out for help.

“I have had a full client caseload,” she said. “In addition, I have had new clients booking and clients from years ago returning.”

O’Mara advises her clients to “take it day by day, hour by hour, minute by minute, if you have to,” and to “stay focused on the present because anxiety exists in the future.”

According to O’Mara, some mental health concerns that could crop up because of the pandemic include:

• Heightened anxiety
• Catastrophic thinking
• Increased depression
• Feelings of being stuck or trapped
• A sense of anger at being told what to do

The coronavirus lockdown is also especially triggering for people with a previous history of mental health concerns.

“If an individual has a history of post-traumatic stress disorder, anxiety disorder, depression or even suicidal ideation the coronavirus shutdown and stay-at-home orders can result in a relapse or an increase in symptoms,” Támara Hill, a licensed child and family therapist and certified trauma therapist in Pennsylvania told Drugwatch.

“For example, imagine someone with claustrophobia or somebody with chronic depression being told that they can’t do the things they are used to,” Hill said. “Being forced to stay in a place where you don’t want to be is a major health concern for many individuals who benefit from the outdoors and socializing with other people.”

Hill says children and adolescents who are more active and spend time at school with friends or at after-school activities are having their lives disrupted, and it could lead to childhood depression and anxiety.

“I encourage my clients to make the best of the shutdown by engaging in activities that would help them grow and continue to advance,” Hill said.

People who take mental health medications should make sure they don’t run out. Suddenly stopping these medications can lead to withdrawal side effects.

For people who can’t meet with their psychiatrists in person, telepsychiatry is a good option. Talk to your health insurance companies for options.

Tips from O’Mara and Hill on coping with coronavirus include:

• Get a hobby
• Get outside for a walk, run or a bike ride
• Have a nice meal
• Have virtual hangouts with friends and family and keep the connection on while you watch a movie or eat dinner
• Keep a journal
• Limit social media and news intake
• Meditate
• Organize your house, closets or garage
• Read a book
• Relax in a warm bath or shower every night
• Start a home improvement project

Relaxation Tip

Taking a few minutes to breathe and relax does wonders for mental health. If you’re new to meditation or breathing exercises, YouTube has several guided meditations to follow. There are also apps for your phone. Or try University of Michigan’s suggested breathing exercises to relieve stress.

Need Help Right Away?

Until a vaccine becomes available, the best way to protect yourself and others from COVID-19 is to avoid exposure to the virus, according to the CDC. The CDC has issued the following guidelines for prevention.

People Most at Risk

Although anyone can contract COVID-19, the most vulnerable people are those older than 60 and those with underlying health conditions.

According to a report by the WHO-China Joint Mission on Coronavirus Disease 2019, among the 55,924 confirmed cases studied, the highest death rate was in people over 80 years old. Men died more often than women.

In the U.S., the CDC says, 8 out of 10 reported deaths have been in people 65 or older.

People with the following conditions are at greater risk of infection or severe illness:

• Chronic kidney disease and conditions that require dialysis
• Chronic lung disease
• Compromised immune system
• Diabetes
• Liver disease
• Moderate to severe asthma
• Serious heart conditions
• Severe obesity (BMI 40 or higher)

People undergoing cancer treatment or with poorly controlled HIV or AIDS are among those at greater risk. Also included are smokers, bone marrow or organ transplant recipients, and people who take medications that weaken the immune system, such as prolonged use of prednisone and other corticosteroids.

Pregnant People

Based on what the CDC knows as of November 2020, pregnant people are at an increased risk for severe illness from COVID-19 compared to other populations. They may also be at increased risk of preterm birth and other complications.

In pregnant women with COVID-19 symptoms, admission to intensive care, ventilator use and death were more likely than in women who were not pregnant, the CDC said in a Nov. 6, 2020 report.

From Jan. 22 to Dec. 7, 2020, there were 44,183 pregnant women with COVID-19 and 57 deaths, the agency reported.

The CDC urges pregnant people to use measures to prevent infection, such as social distancing, hand washing and mask wearing. Pregnant people should also limit interactions with people who might have been exposed to or infected with COVID-19.

It’s uncommon for mothers with COVID-19 to pass their infection on to newborns, but some babies have tested positive after birth. Most newborns who tested positive had mild or no symptoms and recovered.

There is no evidence that COVID-19 can pass to babies through breastmilk. Sick people who choose to breastfeed should wash their hands before each feeding and wear a face mask. If using a breast pump, make sure to wash hands and clean the pump and bottle parts before expressing breastmilk. It’s better to have someone who is not sick feed the baby if possible.

Seniors

Seniors are an especially vulnerable population. They are at the most risk of infection and having severe illness. Social distancing is especially important for them.

In order to make shopping more comfortable for seniors and others most at risk, several stores with essentials and groceries reserved special times for seniors-only shopping. Contact local stores to learn about their protocols.

NURSING HOMES AND ASSISTED LIVING FACILITIES

Since March 13, 2020, many nursing homes and assisted living facilities have been on lockdown to prevent the spread of the virus, according to AARP. As a result, many residents have been cut off from their families and have not been allowed much socializing time because of social distancing guidelines.

However, Michael Dark, staff attorney at California Advocates for Nursing Home Reform in San Francisco told AARP that residents can still use email, FaceTime, Skype or make a telephone call to keep in touch with family.

Residents and family members should “stay in touch with your facility and closely monitor their messages. You can ask the facility about their infection plan,” Terry Fulmer of the John A. Hartford Foundation, a New York City-based national group dedicated to improving the care of older adults, told AARP.

The CDC recommends against moving older adults from long-term care centers because they generally need higher levels of care and may be more susceptible to germs outside of the facility.

Other experts say that if family members have the resources to care for a family member, they can make the decision to bring their loved one home. But it’s important to first talk to the facility about how to provide the necessary care at home.

The most common symptoms are cough, shortness of breath and fever. The first signs of the coronavirus infection appear between two to 14 days after exposure, according to CDC.

WHO studied 55,924 confirmed coronavirus cases in China. It found about 7,700 people (13.8 percent) developed severe disease. About 3,400 people (6.1 percent) had critical disease with septic shock, respiratory failure and/or organ failure.

Children tended to have milder symptoms. Only about 1,300 (2.4 percent) of the 55,924 people with COVID-19 were under 19 years old. Of those children, about 2 (0.2 percent) died.

As of Feb. 20, 2020, and based on 55,924 confirmed cases, the most frequently reported symptoms from patients with COVID-19 were fever, dry cough and fatigue.

Cold, Flu, Allergies or the Coronavirus?

Many Americans may suffer from seasonal allergies, a common cold or the flu. It can be difficult to tell if someone is sick or having a reaction to pollen and other springtime irritants.

Allergies aren’t contagious and never cause a fever, which is one of the telltale symptoms of flu or the coronavirus.

The common cold is marked by stuffy or runny nose and sneezing, and these symptoms are rare with the flu or the coronavirus.

The flu shares many of the same symptoms with the coronavirus, though flu sufferers have more prominent headaches and chills and don’t suffer from shortness of breath, an early sign of the coronavirus.

Symptoms and severity can be different depending on a person’s general health.

Researchers’ understanding of COVID-19 changes rapidly. Below are the facts reported by the CDC, WHO, the National Institutes of Health and Johns Hopkins University as of June 19, 2020. These facts may change as the situation evolves.

Researchers first discovered the virus when a pneumonia of unknown cause in the city of Wuhan in Hubei province, China, was reported to the WHO China Country Office on Dec. 31, 2019, according to the World Health Organization.

On March 11, 2020, WHO officially declared COVID-19 a pandemic, or a global outbreak of disease spread from person to person.

New viruses to which people have no immunity cause pandemics. Two other examples of pandemics are the Spanish influenza that killed approximately 50 million people in 1918 and H1N1 influenza virus in 2009.

The U.S. had its first reported COVID-19 case on Jan. 21, 2020, according to the CDC. Since then, the virus has infected millions of people. The CDC has received reports of COVID-19 cases from all 50 states.

Since China reported the first possible case to WHO in December 2019, the coronavirus situation has been evolving rapidly because of the disease’s quick spread.