Vaccines and Birth Control and Blood Clots...Oh My.

On April 13th, the CDC and FDA recommended a pause in the use of the Johnson & Johnson (J&J) COVID-19 vaccine after a small number of recipients developed severe blood clot-related side effects after receiving the vaccine. While there were only six reported cases (all women) out of more than 6.8M J&J vaccines administered at that time, evidence showed that the usual blood clot treatment, heparin, would be dangerous, so the FDA and CDC recommended the pause out of an abundance of caution while additional analysis was conducted.

The move sparked controversy across social media, with users juxtaposing the close attention and widespread media coverage of such rare side effects (literally one in a million) with the ongoing lack of conversation and concern for the 1 in 1,000 people who risk blood clots as a side effect of taking hormonal birth control.

Then, on April 23rd, the CDC and FDA lifted the pause, confident that the benefits of the vaccine far outweighed the rare side effects. As such, the J&J vaccine is again being distributed throughout the United States. They’ve now identified 15 total cases of thrombosis-thrombocytopenia syndrome (TTS) caused by the J&J vaccine. TTS is when a type of blood clot called cerebral venous sinus thrombosis (CVST) occurs in combination with low levels of blood platelets (thrombocytopenia). The data shows that overall the risks of these side effects are very low and the vaccine is safe and effective for preventing COVID-19. If you want more information, the FDA has provided this fact sheet.

The last few weeks have been full of op-eds and breakdowns of the blood clot controversy (CNN, Dazed, TeenVogue, Independent, US News & World Report, to link just a few). Here at Emme, we are encouraged that the medical establishment and  mainstream media, having long under-invested in women’s health research and outcomes, are turning their attention to the effects medication on women, specifically. We wanted to take a step back from the news cycle to reflect on what we’ve learned from this highly public discussion around the risks we take on when we make decisions to keep ourselves healthy.

The COVID-19 vaccine is safe. Hormonal birth control is safe.

There are potential side effects to monitor, risk factors you should be aware of and discuss with your provider — but the benefits outweigh the costs. Learn more below.

• How safe is the birth control pill — Planned Parenthood
• Hormonal Birth Control: Risk of Blood Clots — University of Michigan Medicine
• Reproductive Health Resources — CDC
• J&J Covid-19 Vaccine — J&J.com
• CDC Factsheet on the Vaccine — CDC

Scientific data is hard to interpret for normal folks, and statistics can be misleading.

Much of the conversation focused on a comparison between “6 out of 7M” blood clots from vaccines and “1 in 1,000” blood clots from birth control. This comparison is misleading, though, as they refer to two very different types of blood clots. The CVST blood clots seen after the J&J vaccine are rare and severe (directly affecting the brain), causing serious symptoms, and are difficult to treat. The more common side effects of birth control are Deep Vein Thrombosis and Pulmonary Embolism (DVT/PE) , which often has minor (or no) symptoms and requires simpler treatment.

We need more research on the impact birth control has on our bodies.

A 2015 meta-analysis of 11 studies analyzed oral contraceptive pill use in women 15-50 and found that the pill increased the risk of CVST by more than 7.5x. Yes, the same rare and severe CVST that had doctors concerned with the J&J vaccine. So, while directly comparing the numbers above isn’t possible, the central point remains — funding is needed so that we, the public, can better understand what the side effects are, who is most at risk, and how to treat them.

We should all be talking about risks like these more often.

DVT/PE being less severe than CVST doesn’t mean that these complications of hormonal birth control aren’t important. Some birth control users first found out about the blood clot risks just last week. The mile-long side effects lists in tiny print aren’t enough. Healthcare providers need to understand the side effects of various types of birth control, the risk factors for DVT/PE and other side effects, and the particular context and goals of each patient. And they need to communicate those risks in an easily accessible and understood way.

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Sources:

1. Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine (FDA.gov)
2. Risk prediction of developing venous thrombosis in combined oral contraceptive users (NIH.gov)
3. Twitter posts (1) and (2) and (3) and (4)
4. FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety Review (FDA.gov)
5. Fact Sheet for Recipients and Caregivers (FDA.gov)
6. J&J vaccine pause prompts a needed discussion of women's health (CNN)
7. The conversation we should be having about blood clots (Dazed Digital)
8. If we’re concerned about vaccine blood clots, should we be worried about the pill too? (The Independent)
9. The Johnson & Johnson Vaccine Pause is a Step Toward Taking Women's Health More Seriously (Teen Vogue)
10. Don’t Compare Blood Clots After the Johnson and Johnson Vaccine to Birth Control Risk (US News)
11. How safe is the birth control pill -(PlannedParenthood.org)
12. Hormonal Birth Control: Risk of Blood Clots (UofMHealth.org)
13. Reproductive Health Resources (CDC.gov)
14. J&J Covid-19 Vaccine (JnJ.com)
15. CDC Factsheet on the Vaccine (CDC.gov)
16. Deep vein thrombosis (DVT) (CDC.gov)
17. Hormonal Contraceptives and Cerebral Venous Thrombosis Risk: A Systematic Review and Meta-Analysis (NIH.gov)Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine (FDA.gov)
18. Risk prediction of developing venous thrombosis in combined oral contraceptive users (NIH.gov)
19. Twitter posts (1) and (2) and (3) and (4)
20. FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety Review (FDA.gov)
21. Fact Sheet for Recipients and Caregivers (FDA.gov)
22. J&J vaccine pause prompts a needed discussion of women's health (CNN)
23. The conversation we should be having about blood clots (Dazed Digital)
24. If we’re concerned about vaccine blood clots, should we be worried about the pill too? (The Independent)
25. The Johnson & Johnson Vaccine Pause is a Step Toward Taking Women's Health More Seriously (Teen Vogue)
26. Don’t Compare Blood Clots After the Johnson and Johnson Vaccine to Birth Control Risk (US News)
27. How safe is the birth control pill (PlannedParenthood.org)
28. Hormonal Birth Control: Risk of Blood Clots (UofMHealth.org)
29. Reproductive Health Resources (CDC.gov)
30. J&J Covid-19 Vaccine (JnJ.com)
31. CDC Factsheet on the Vaccine (CDC.gov)
32. Deep vein thrombosis (DVT) (CDC.gov)
33. Hormonal Contraceptives and Cerebral Venous Thrombosis Risk: A Systematic Review and Meta-Analysis (NIH.gov)