To help you sort through the news on the COVID-19 vaccine’s progress, MedShadow has created the MedShadow Vaccine Tracker, the only tracker focused on the side effects and adverse events associated with proposed COVID-19 vaccinations.
Some risks and minor side effects, such as a sore arm where the vaccine is injected or a light skin rash, are clearly worth the benefit of being protected against a disease. Where to draw the line at what is or is not acceptable is a personal decision. That’s where the MedShadow Vaccine Tracker can help.
On the tracker, we will be publishing up-to-date Phase 3 results information about the risks of each vaccination. Phase 3 tests the vaccine for safety and efficacy in large groups of people (tens of thousands) and is the last stage before the FDA considers approval for use in the population at large.
Moderna started Phase III clinical trials for its vaccine candidate in July. In earlier trials, nearly half of patients experienced common adverse effects like injection site pain, rash, headaches, muscle soreness, nausea and fevers after the second injection. These effects generally subsided within two days. So far, no other serious or unusual effects have been reported. CNBC spoke to a few individuals, some participating in Moderna’s trial and some in Pfizer’s trial who said much the same thing: the side effects were intense and included a high fever body aches, bad headaches and exhaustion in addition to the more common side effects, but worth it for protection from Covid-19. The company released a press release about interim results of the Phase III trial, which said that 2.7% of patients had injection site pain after the first dose. After the second dose patients reported more side effects including fatigue (9.7%), myalgia (8.9%), arthralgia (5.2%), headache (4.5%), pain (4.1%) and erythema/redness at the injection site (2.0%). The report emphasized “these solicited adverse events were generally short-lived.”
Pfizer began Phase III clinical trial for its vaccine candidate in July. In earlier trials, some patients experienced common adverse effects like injection site pain, rash, headaches, muscle soreness, nausea and fevers. These effects generally subsided within two days. So far, no other serious or unusual side effects have been reported. CNBC spoke to a few individuals, some participating in Pfizer’s trial and others in Moderna’s trial who said much the same thing: the side effects were intense and included a high fever body aches, bad headaches and exhaustion in addition to the more common side effects, but worth it for protection from Covid-19. Recently, some patients described the side effects as being similar to a bad hangover.
China granted the CanSinBio vaccine emergency approval prior to beginning a Phase III trial in August. In the Phase II trial, nearly three-quarters of patients reported at least one common mild adverse events including injection site pain, rash, headaches, muscle soreness, and fevers. Five people also reported vomiting.
Gamaleya Research Institute launched Phase III trials in August. But before they got started, President Putin announced that the vaccine was approved early, however, the Phase III trials are expected to continue. In the earlier trials, almost all of the patients experienced low-grade fevers. A small number of patients reported heart palpitations. Otherwise, reported side effects were similar to other vaccines and included injection site pain, rash, headaches, and muscle soreness.
Johnson & Johnson started a Phase III trial for its vaccine candidate in September, but paused it on October 12 due to an unexplained illness and remains on hold. The company announced it would restart the trial on October 26. Pauses are common during clinical trials to evaluate specific adverse events, but the company has not shared details about the illness experienced by one of the trial volunteers. In earlier trials, about 70% of patients experienced at least one mild adverse effect similar to those seen with other vaccines, including injection site pain, rash, headaches, muscle soreness, and fevers.
On September 6, the company paused the trial to investigate a patient who developed transverse myelitis – dangerous inflammation of the spinal cord. Researchers determined that the incident was unrelated to the vaccine and quickly restarted the trial in most countries, however it remained paused in the US until October 26. On October 21, scientists reported a patient in the trial had died, however, according to a local newspaper, the patient was in the control arm of the trial, meaning they’d received a placebo instead of the vaccine, so the trial is ongoing.
In earlier trials, many patients reported mild adverse effects similar to those associated with the other vaccines including injection site pain, rash, headaches, muscle soreness, and fevers. The team gave some of these patients preventative acetaminophen to reduce pain and fever. Nearly half of patients also experienced temporary neutropenia – a reduction in white blood cells that can make a person more susceptible to infections.
Novavax began Phase III clinical trials with its vaccine candidate in the United Kingdom in September and is planning to start a trial in the United States this month (October). During Phase I/II trials, patients reported adverse events similar to those of other vaccine candidates, including injection site pain, rash, headaches, muscle pain, fever, nausea and vomiting.
In July, Sinopharm launched Phase III trials of its two vaccine candidates in the United Arab Emirates, Peru, Morocco, and Argentina, which are now approved for limited use in healthcare workers in China and the UAE. In earlier trials of one of the vaccines, made in collaboration with Wuhan Institute of Biological Products, about 15% of the patients reported adverse events similar to those of other vaccine candidates, including injection site pain, rash, headaches, muscle pain, fever, nausea and vomiting. There is little data available about the second vaccine, made in collaboration with the Beijing Institute of Biological Products.
Sinovac opened Phase III trials of its vaccine candidate, CoronaVac, in July. It is already being used with emergency approval for high risk individuals in China. The earlier trials showed that about a third of patients experienced adverse effects similar to those in other vaccine candidates like injection site pain, fever, and fatigue, but the study included few details about more specific symptoms like nausea, headaches, and vomiting. On November 10, the trial was halted in Brazil due to a participant’s death. However, researchers say the death was not vaccine-related and the trial should continue. It has not been halted in other countries.
The Murdoch Children’s Research Institute is running a Phase III trial repurposing Bacillus Calmette-Guerin — a vaccine developed nearly a century ago to prevent tuberculosis infections — to prevent Covid-19. Since the vaccine has been around such a long time, there are many reports on its potential adverse effects and the vaccine itself has been altered to minimize many of them. Injection site reactions are common, and lymphadenitis, swelling of the lymph nodes, is common.