Last week I went over the basics of how vaccines work and specifically how the first three COVID-19 vaccines work. This week I’ll cover safety.
There has been a lot of press over the last few months regarding public concern about the safety of COVID-19 vaccines. This greatly concerns those of us in public health because we simply won’t get control of this pandemic if the vaccines don’t become vaccinations in peoples’ arms.
Certainly, there was concern that COVID-19 vaccines were becoming a political football and that they might be released without being properly vetted for safety. Naming the program to produce the vaccines “Operation Warp Speed” also caused concerns that short cuts were being taken to get the vaccine out as quickly as possible.
The majority of vaccines have historically taken 10-15 years to develop. The COVID vaccines have taken less than a year. How can this possibly be safe? Vaccine research and development is typically a very slow process, primarily due to the costs involved and the extremely high risk vs. reward (i.e. profit) ratio. Most of the COVID-19 vaccines in development are based on improving vaccine methodologies that have already been studied for at least ten years for other diseases like Ebola and Zika.
Most of the costs of vaccine development go to funding clinical trials. Despite what you may have read, there is usually not a lot of money to be made in bringing a vaccine to market. That’s why there are a limited number of companies that produce them.
To remove the financial risk and incentivize vaccine developers, Operation Warp Speed was hatched by the federal government to provide up to $10 billion in capital for development and manufacture of vaccines and other therapeutics for COVID-19. For example, moderna has received nearly $2.5 billion to deliver 100 million doses, and AstraZeneca/Oxford $1.2 billion for vaccine development and manufacture. While Pfizer used its own money to fund its research and development, it was paid $1.95 billion by the government to purchase Pfizer’s first 100 million doses with an option to purchase 500 million more.
When vaccine manufacturers no longer had to worry about losing their shirts, they were able to pour our tax dollars into the equipment, staffing, and clinical trials required to bring these vaccines to market in astonishing time. The companies had no financial reason to cut corners. The vaccine trials have also enrolled tens of thousands of participants, that is typical of historical vaccine studies. Operation Warp Speed also required trials to include patients from multiple ethnic and minority groups to ensure safety and efficacy.
Operation Warp Speed has also allowed something that has never been done - pharmaceutical companies have not only been able to do the necessary research, but have concurrently manufactured the vaccines while clinical trials were taking place. If trials show one or more of the vaccines to be ineffective or unsafe, all the vaccine that was produced will be dumped into the trash.
Vaccine safety data are not vetted by the manufacturers or the government. The companies must present clinical trial data to an independent data and safety monitoring board (DSMB). The board is composed of 10-15 expert clinicians, vaccinologists, immunologists, and statisticians who pore over the raw data and determine the efficacy and safety of the product. The identities of the members are kept hidden to avoid improper influence.
The DSMB’s recommendation is sent to the FDA for approval. Dr. Stephen Hahn, FDA Commissioner, made it clear the FDA would not grant authorization for a COVID vaccine without seeing two months of safety data. Virtually all serious safety problems with vaccines are seen in the first six weeks of their distribution. The vaccine manufacturers also signed a statement that they would follow the science rather than be beholden to an artificial political deadline.
Despite having what appear to be at least three good vaccines for COVID, we are very concerned about the general public declining vaccination, also known as “vaccine hesitancy.” This is a trend that has been growing with many vaccines, particularly pediatric vaccinations. I won’t go down the rabbit hole of why this has become a thing, but much of it traces back to our lack of educating the public about vaccines and misinformation/disinformation being disseminated on social media.
An October poll performed by STAT and The Harris Poll revealed that overall, 58% of the U.S. population would take the vaccine as soon as it was available (down from 69% in mid-August). The poll is even more striking when acceptance by race was examined. The poll found that 59% of white Americans would take the vaccine (70% in mid-August) but only 43% of black Americans would take it (65% in mid-August). This is extremely concerning since blacks are more likely to contract and die from COVID-19.
People need to be informed that vaccines being “safe” does NOT mean they won’t have reactions to them. Every vaccine has its own “reactogenicity” profile. Some cause few reactions, while others have more severe ones. It’s particularly critical that people who receive a vaccine requiring a booster dose return for their booster, so it’s very important for them to understand there will be significant reactions.
The current COVID vaccines, particularly the moderna and Pfizer ones, do produce significant reactions, likely to the fatty nanoparticles that encapsulate the messenger RNA. These include fever, body aches, headache, and fatigue, among others. It’s also important for people to remember that reactions to a vaccine are much safer than being infected naturally.
Also note that fever is a normal reaction to infection and immunization and that it actually improves your immune response to the infection or vaccine. So, when you get the vaccine, try not to take medication to reduce your fever since it may blunt your response.
When the vaccines are approved by the FDA, what’s the process for getting them into the arms of Americans? I’ll address that next week.