The FDA Lifts Pause on Johnson & Johnson Vaccine
Updated: Jun 5, 2021
On April 23, the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) officially lifted the recommended pause of U.S. distribution of the Johnson & Johnson COVID-19 vaccine. This news came about 10 days after the recommended pause was set in place amid possible safety concerns of rare blood clot formation following vaccination. The use of the vaccine has since been resumed due to conclusions that its known and potential benefits outweigh the known and potential risks of severe side effects from both the vaccine and COVID-19. The issue of health equity for population subsets who face greater barriers accessing medical appointments and might be disproportionately affected by its restriction is also raised.
An in-depth analysis found that the association between the Johnson & Johnson vaccine and the rare blood clotting condition called thrombosis with thrombocytopenia syndrome (TTS) is very low. This conclusion came after experts found that the overall rate of TTS occurrence was about 1.9 cases per one million vaccine doses and about 7 cases per million for women ages 18 to 49. The case rate for women over 50 was 0.9 cases per million and there were no cases among men who received the vaccine. In total, 15 women developed TTS and three died out of about 7 million individuals who received the Johnson & Johnson vaccine up until the time its use was paused.
The risk of blood clotting from those infected with COVID-19 was found to be higher than from being vaccinated with the Johnson & Johnson vaccine— approximately 147,000 out of a million individuals hospitalized with the coronavirus versus two individuals out of one million who received the vaccine. After confirming these numbers, the CDC's Advisory Committee for Immunization Practices recommended lifting the pause and adding a warning label to advise of the small risk. The FDA also updated its vaccine facts sheets for Johnson & Johnson to reflect the advised caution for women under the age of 50 seeking vaccination.
The CDC also presented models calculating what could happen with the vaccine being used again in terms of deaths or TTS cases. These models are in congruence with different group restriction scenarios compared to outcomes from COVID-19 infections. With the resumption of the Johnson & Johnson vaccination among all individuals 18 and older, the U.S. could expect to see 26 to 45 additional TTS cases. However, 600 to 1,400 deaths related to COVID-19 and 3,500 intensive care unit (ICU) deaths could be prevented. If the vaccine were to be restricted to adults over the age of 50, only three additional TTS cases could be expected, but only 40 to 250 COVID-19 deaths and 1,000 ICU admissions would most likely be avoided in comparison.
Some experts expressed concerns in regards to withholding the single-dose vaccine. Withholding it can increase the level of difficulty for some people to get vaccinated against COVID-19, such as those who cannot take as much time off work to get a second dose from another vaccine option. Having the option to get fully vaccinated with one dose increases accessibility for those living in hard-to-reach geographical areas, or who otherwise face hurdles with accessing medical care such as homeless, housebound, incarcerated, or seasonal migrant populations. The Johnson & Johnson vaccine also does not require deep freezer storage, further increasing convenience and efficiency for hospitals and clinics in maintaining a steady vaccine supply more easily. Keeping a one-dose vaccine available can help control the COVID-19 transmission and improve health equity by decreasing barriers of access associated with needing multiple clinic visits for two-dose vaccines.
Although the potential side effects from the Johnson & Johnson vaccine still exist, the benefits of slowing transmission and reducing the severity of complications or death from COVID-19 infections outweigh those risks for most individuals. The initial pause of its use by the CDC and FDA was recommended out of an abundance of caution to ensure maximum safety for the U.S. population. After a thorough review of the observed TTS cases, the Advisory Committee for Immunization Practices concluded that the Johnson & Johnson vaccine meets CDC standards for safety, quality, and effectiveness. It is important to remember that while a small risk for blood clots exists from this vaccination, the risk of blood clotting from COVID-19 infection is higher. With a new warning label added to inform individuals, a resume in the administering of this effective and convenient single-dose vaccine will be essential in efforts to slow the spread of COVID-19 in the U.S.
On April 23, 2021, the FDA and CDC lifted the recommended pause on the use of the Johnson & Johnson vaccine initially put in place about 10 days prior.
Distribution of the Johnson & Johnson vaccine in the U.S. was recommended to pause due to potential safety concerns after 15 individuals out of about 7 million who received the vaccine developed rare and severe blood clotting disorders.
The risk of developing blood clots is approximately 147,000 out of a million individuals hospitalized with COVID-19 versus two individuals out of one million who received the Johnson & Johnson vaccine.
The Johnson & Johnson vaccine presents a convenience factor in efforts to slow the pandemic due to requiring only one dose and no need for deep freeze storage for population subsets who face barriers accessing healthcare.
The CDC’s Advisory Committee for Immunization Practices recommended lifting the pause after concluding that the known and potential benefits of vaccination outweigh its known and potential risks, and those of COVID-19.