Early April 13th, the FDA announced they would be pausing the roll-out of all single-dose Johnson & Johnson vaccines after 6 women between the ages of 18 and 48 out of 6.8 million people who had received the vaccine had experienced blood clots. One woman died of a blood clot, and another has been hospitalized, per the New York Times.The move to pause the rollout in order to further look at the vaccine and ensure that it is safe has been done out of an over-abundance of caution — but unfortunately, there are many fears that pausing the rollout to evaluate these concerns will lead many people to believe that the J&J vaccine isn’t safe, despite the fact that, based on the rollout so far, there’s less than a 1 in a million chance in getting a blood clot after receiving the vaccine, and so far, there is no proven causal relationship.For context, there’s a 1 in 1,000 chance that a woman on birth control will develop blood clots while on the fertility drug, and the CDC says about 900,000 Americans could experience blood clots in a given year (1-2 out of 1,000) — out of 328 million residents of the country. The blood clot disorder that is being investigated, cerebral venous sinus thrombosis, is very rare. And that’s only if it’s proven to be associated with the vaccine. If you’re confused about the pause, concerned about the safety and/or efficacy of the Johnson & Johnson vaccine, and want to know what it means for the fight to reach herd immunity in the United States, you’re in the right place. Here’s what you need to know.
Why Did The FDA Pause The Rollout?
The FDA paused the rollout after six women out of 6.8 million recipients of the J&J vaccine developed blood clots, one of whom died and another one who was hospitalized. “Right now, these adverse events appear to be extremely rare,” the FDA said in a Twitter statement. The federal government will likely pause giving out the vaccine at all federal vaccination sites and will expect state officials to do the same. While the rollout is paused, the CDC and FDA will look over the data and see if there’s a link between the vaccine and blood clots that are statistically relevant. They could determine whether or not they will change who they authorize the vaccine for, for example, if data suggests the vaccine is unsafe for certain population groups or if the data confirms that this ultra-rare side effect is just that. Johnson & Johnson responded to the news saying: “We are aware that thromboembolic events including those with thrombocytopenia have been reported with COVID-19 vaccines… No clear causal relationship has been established between these rare events and the Janssen COVID vaccine.” The 6 women out of 6.8 million people who developed the blood clots did so within two weeks of getting the vaccine.
What Are Concerns About Pausing the Rollout?
Many rightly fear that pausing the vaccine rollout will lead many people to believe that the Johnson & Johnson vaccine is unsafe. And at a time when the battle of vaccination is between rapidly rising COVID-19 variants and getting people vaccinated against said variants, any pause in rolling out inoculation could put people (and kids in particular) at risk of getting COVID-19 for longer.At the same time, pausing the rollout is a necessity for the FDA and CDC. Even a whiff of not investigating the efficacy and safety claims could delegitimize the entire operation. It’s a little bit of a damned if you do (pausing will make people think the vaccine isn’t safe), damned if you don’t (not pausing will make people think the government is repressing vaccine data).
Is The Vaccine Safe and Effective?
All data suggests that the J&J vaccine is safe and effective in combating COVID-19 illness, hospitalization, and death. Right now, the relationship between the extremely, ultra-rare blood clots and the J&J vaccine is not considered to be causal. The pause in the rollout is to determine if there is a link between the two.And if it were causal (a giant ‘if’ that should not stick until the government proves it), current data shows there’s a higher chance of developing a blood clot in normal life, or when taking birth control, than getting a vaccine that protects you against a virus that has killed 562,000+ Americans out of 31.3 million confirmed cases.
What Does This Mean For Vaccine Appointments?
The pause in rolling out J&J comes at a time when the overall supply of the vaccine is about to drop mightily after a Baltimore plant manufacturing the vaccine has come under fire for sub-par manufacturing conditions. 13 million out of 15 million made doses were discarded, and none of the other 62 million doses that were manufactured there can be distributed to the public, which would allay concerns of vaccine safety but is bad news for the rollout in general. The overall supply of the convenient one-shot dose will plunge by 86 percent.Local vaccine sites are shifting appointments around right now to offer the Pfizer and Moderna vaccines to those who were scheduled to receive the Johnson & Johnson vaccine. If you have an upcoming J&J appointment, contact your local officials to see what they are doing about the vaccine news. You could still get a vaccine dose, which would still be a step forward in vaccinating the population and reaching herd immunity.
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