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Will Full FDA Approval for Pfizer COVID-19 Vaccine Reduce Vaccine Hesitancy?

September 8, 2021

The United States Food & Drug Administration (FDA) recently gave full approval to the Pfizer-BioNTeck COVID-19 vaccine for people aged 16 years and older. Experts hope that this new designation will help counter vaccine hesitancy. Vaccine study trials need two months of data to apply for emergency use. Full approval requires at least six months.

The vaccine, which was previously available under emergency use authorization (EUA) along with the Moderna and Johnson & Johnson vaccines, will be called Comirnaty.

What is vaccine hesitancy?

Vaccine hesitancy and anti-vaccination ideas have been around since vaccinations first came to be, but it has gotten worse over the past few decades. The World Health Organization (WHO) places some of the blame on infodemics.

An infodemic is when too much information, including false or misleading information, is present in digital and physical environments during a disease outbreak. It causes confusion and risk-taking behaviours that can harm health. It also leads to mistrust in health authorities and undermines the public health response. An infodemic can intensify or lengthen outbreaks when people are unsure about what they need to do to protect their health and the health of people around them. With growing digitization – an expansion of social media and internet use – information can spread more rapidly. This can help to more quickly fill information voids but can also amplify harmful messages.

Vaccine hesitancy is not the same thing as the anti-vaccination movement, which has led to outbreaks of preventable diseases, like measles. Rather than being against vaccines, the issues around vaccine hesitancy are more complex than the anti-vaccination issue. People who are vaccine hesitant often delay only certain injections. They may not have concerns about other vaccines, such as the ones against whooping cough or polio, but they are concerned about newer ones that haven’t been around for as long. People who are vaccine hesitant may also not be sure if they need the vaccine. If asked, they often say they are waiting to see how others react to the vaccine over time.

The COVID-19 vaccines’ rapid use could be indirectly responsible for some of today’s hesitancy. Historically, it has taken decades to develop a vaccine. The public is used to hearing about the many years it takes to bring a medical or health product to market. What happened behind the scenes sped up the process when it came to COVID-19 and vaccines. The many years of research and manufacturing vaccines provided a good head start for the fast and coordinated response from the global scientific research community. The mountain of knowledge from previous work and the fact that the scientists worked together and shared information contributed to the rapid COVD-19 vaccine development and production in record time.

Countering vaccine hesitancy

You may know vaccine-hesitant people. Being unsure of something new is not unusual or surprising. Below, we have complied answers to common myths, questions, and comments to help you learn about the new COVID-19 vaccines and combat vaccine hesitancy.

“These vaccines developed too fast for us to trust them.” (myth)

It is true the COVID-19 vaccines became available quite quickly, but not at the expense of safety and efficacy.

Researchers have been working for decades on new and improved medications, including vaccines. That body of knowledge became available worldwide when scientists began learning about the novel coronavirus that caused COVID-19. A big part of research delays lies in paperwork and finding funding. The organizations that oversee the research understood the urgency and eliminated as much time-consuming non-research aspects as possible.

“Not enough people participated in the trials.” (myth)

Each vaccine clinical trial had tens of thousands of participants who were followed for at least two months after the second dose for the Pfizer and Moderna vaccines, and the only dose for the Johnson & Johnson vaccine. Researchers continue to follow the volunteers.

The average enrollment for the final stages of a clinical study usually ranges from several hundred to about 3,000 people.

“Why do I need the vaccine if I have a healthy immune system?”

Just as we don’t know why two people get the same infection and one gets sepsis and the other doesn’t, we don’t know why some people are able to fight off COVID-19 with mild symptoms while others develop viral sepsis and become extremely ill or die.

Originally, COVID-19 was deadliest mostly among the very old and those with chronic illnesses, but as the second and subsequent waves occurred, newer variants became stronger and spread faster, the disease caused more serious illness. Healthy young adults and children are becoming sicker with COVID-19 now than they did when the pandemic began. Vaccine hesitancy has resulted in many people in the hospital, fighting COVID-19, to ask for the vaccine when it’s too late.

“I’ve heard there are serious side effects.”

All medications can potentially cause side effects, vaccines included. The most common side effects from the COVID-19 vaccines are pain and redness at the injection site, as well as:

  • Fatigue
  • Fever
  • Muscle pain
  • Nausea
  • Headache
  • Chills

These effects occur as your body responds to the vaccine and are normal. They usually only last a day or two.

There are some potentially serious side effects, but they are rare. They include:

  • Blood clots
  • Shortness of breath
  • Chest pain
  • Easy bruising
  • Inflammation around the heart
  • Guillain-Barre syndrome (GBS)

As of August 23, 2021, there were 44 confirmed reports of a blood clots and 167 possible reports of GBS out of more than 14 million doses of Johnson & Johnson’s vaccine. There were 778 cases of heart inflammation among the more than 363 million doses of the mRNA vaccines and Johnson & Johnson. For comparison, one in every 3,000 healthy women who take birth control pills are at risk of getting blood clots.

“If you can still get COVID after getting a vaccination, what is the point?”

It is true that fully vaccinated people can contract COVID-19. However, the vaccine lowers the risk of the illness becoming so severe that you must go to the hospital. It also reduces the risk of dying from the infection. In some families, some members were vaccinated, others were not. Sadly, there have been news reports of unvaccinated people who were admitted to the intensive care unit and others died, while the vaccinated family members recovered after mild to moderate symptoms.

“Why do I need two shots?”

Many vaccines, including for hepatitis and shingles, require more than one dose. Others, like for tetanus, require boosters. It is common to need more than one shot of a particular vaccine. The first injection provides partial protection only.

“I’m going to wait until the vaccine has been around for longer.”

It is true that the vaccines against the virus that causes COVID-19 are new and this contributes to vaccine hesitancy. But they are not unproven. The research has proven that the currently available vaccines do prevent most cases of severe COVID-19.

As of the end of August 2021, over 5 billion doses of COVID-19 vaccines have been administered around the world. Almost 2 billion people received full vaccination. In the United States, around 365 million people have received at least one dose.

“I can’t afford to take time off if I have a day or two of bad side effects.”

Taking time off work to get a vaccine can be difficult for many people, particularly those in lower paying jobs. Combine work responsibility with family and other issues, it can seem impossible to take the time for a vaccine that could make you sick for a day or two. This can contribute to vaccine hesitancy. That being said, can you afford to be off work for several weeks if you become ill with COVID-19 or have to care for a loved one who is ill? Could you manage being off work for several months if you needed to go through rehab or live with long COVID or post-sepsis syndrome?

If you are concerned about being able to work after the vaccine, try scheduling an appointment before the weekend or a day off. Speak with your manager to see how you can schedule your vaccine with the least amount of stress. Perhaps the staff could rotate when they get their vaccines, should anyone need to take time off.

If you still have questions

If you still have questions about the COVID-19 vaccines and vaccine hesitancy, speak with your doctor. To read more about the infection and what healthcare professionals and researchers are doing to combat it, visit Sepsis and COVID-19, part of the Sepsis Alliance Sepsis and… library. For more information on how vaccines can help prevent sepsis, visit Sepsis and Prevention: Vaccinations.