Answers to Common Questions About COVID-19 Vaccine Risks

December 18, 2020

The Food and Drug Administration approved the first COVID-19 vaccine Dec. 11 from Pfizer and BioNTech. Approval for Moderna’s vaccine is likely soon to follow. As doses head across the country, employers face decisions on how to handle vaccines in the workplace.

One issue is how to tell employees about vaccine safety, efficacy and availability. There’s a lot of misunderstanding around the vaccine, but these answers to common questions can help.

How was the vaccine developed so quickly?

Since most vaccines take years to bring to market, some might assume safety regulations and oversight were compromised to create the COVID-19 vaccine in less than a year. This isn’t the case. The U.S. government fast-tracked development by:

  • Using lessons learned from other outbreaks like the Zika virus
  • Committing to buy the vaccines upfront, so vaccine makers could build the infrastructure for mass production during clinical trials without financial risk
  • Allowing limited overlap of Phase 1 and 2 trials
  • Using epidemiological data to catalyze clinical trial populations
  • Bringing together expert scientists and regulators from various government agencies
  • Giving clear and product-specific written guidance to vaccine makers

How can we know the vaccine’s long-term effects?

Some questions remain unanswered about long-term effects, particularly with regard to after acquired health conditions. However, if someone has an adverse reaction to a vaccine, it usually happens within six weeks. During COVID-19 vaccine trials, the FDA is requiring manufacturers to follow at least half of the volunteers who got the vaccine for a minimum of two months to check for complications.

Are mRNA vaccines dangerous, and why haven’t they been used before?

The Pfizer-BioNTech COVID-19 vaccine is the first mRNA vaccine approved by the FDA. The Moderna vaccine uses the same technology. But this technology isn’t new. These types of vaccines have been studied for 20 years, but production and manufacturing limitations have hindered commercialization. Now that manufacturing technology has improved and government investment has lowered the financial risk associated with developing production infrastructure, mRNA vaccines are easier and less expensive to make. In many ways, they’re easier and faster to produce than traditional dead and attenuated virus vaccines.

It’s also important to know that mRNA vaccines will not alter the DNA or genetic makeup of the recipient.

Some other vaccines under development use traditional approaches, including dead and attenuated virus modalities. Others use a new technology called a vector virus.

What is emergency use authorization?

The first COVID-19 vaccines applied for, and likely will be approved for use through, an emergency use authorization (EUA). This is only available in limited circumstances. Two things have to happen for medical products to be approved under this type of authorization:

  • The Department of Health and Human Services must declare a public health emergency
  • The HHS and FDA must determine that there are no adequate, approved and available countermeasures to combat the emergency

Both of these events happened early in the COVID-19 pandemic.

Is an EUA easier to get than normal vaccine approval?

Not really. Emergency use authorization doesn't water down the safety and efficacy requirements all new drugs must meet. To get this authorization, the vaccine maker must show, among other things, that:

  1. The known and potential benefits of a product outweigh its known and potential risks. This is very close to the normal process for approval under the Federal Food, Drug and Cosmetic Act.
  2. The product may be effective in preventing serious or life-threatening diseases or conditions caused by the agent identified in the emergency declaration. Authorization can’t be granted if there’s only a modest benefit from the product.  

How does the FDA make sure the vaccines are safe?

The EUA applications and supporting data are closely scrutinized by a highly specialized FDA committee made up of scientists, biostatisticians, and doctors from the FDA, the Centers for Disease Control and Prevention, leading academic medical centers, and private industry. The committee makes a recommendation regarding approval of the vaccine to the full FDA. If the FDA approves the vaccine, a branch of the CDC dedicated to the study of vaccine use makes further recommendations about who should get the vaccine and when.

To make sure that the vaccines applying for emergency use were safe, the FDA told manufacturers the safety data and results they needed to approve a vaccine. These include:

  • Data showing the vaccine prevents or lessens COVID-19 severity in at least half of those vaccinated (the Pfizer-BioNTech and Moderna vaccines were actually over 90% effective)
  • Data from at least one well-designed Phase 3 clinical study with over 3,000 volunteers receiving the vaccine (many of the trials involve 6 to 7 times as many vaccinated volunteers)
  • Sufficient data to assess whether vaccine-induced enhanced respiratory disease, a major concern with vaccines for viruses affecting the lungs, was an issue
  • Information on the vaccine’s approval status by other regulatory bodies, including the World Health Organization and by European Union regulators, or under a separate investigational new drug application
  • Data on the safety of the vaccine chemistry, manufacturing and supply chains and the ability to surge production to meet distribution demands

Social awareness plays a big part in whether someone will get the vaccine. In a November Pew Foundation survey, 60% of those questioned would get the vaccine, but almost as many would be uncomfortable being among the first to get it. To overcome vaccine hesitancy, employers should provide clear, accurate information about the vaccines, especially if they want to require employees to get vaccinated.

Please contact Bob Hearn, Nathan Huff, Reed Russell, or any other member of Phelps’ Health Care, Litigation or Labor and Employment teams if you have questions or need compliance advice and guidance.