A US government-appointed panel of medical experts on Thursday unanimously recommended mRNA COVID vaccines made by Pfizer and Moderna over Johnson & Johnson’s shot, in light of its weaker protection and greater risks.
The panel voted 15-0 in favor of the new guidance, which applies to everyone over 18 years of age.
Centers for Disease Control and Prevention (CDC) director Rochelle Walensky signed off on the measure Thursday evening. “Today’s updated recommendation emphasizes CDC’s commitment to provide real-time scientific information to the American public,” she said in a statement, urging Americans to get vaccinated and boosted against the coronavirus.
The recommendation officially steers the public away from J&J’s drug, which was initially praised because it could be stored at fridge temperature and offered good efficacy against earlier strains of the coronavirus after just one shot.
But evidence later emerged linking it to a rare form of clotting, particularly among women of child-bearing age, causing authorities to briefly halt and then resume its use in April. It has remained a distant third choice of vaccine for Americans ever since.
This week, the Food and Drug Administration found the rate of this effect was higher than previously thought, and not confined to females.
Preliminary lab testing data has also suggested the jab offers very little protection against the new Omicron variant—at least against infection.
“I would not recommend a Janssen vaccine to my family members,” said Beth Bell, a clinical professor at the University of Washington, referring to the vaccine by the name of the J&J subsidiary that developed it.
“On the other hand, I think we do have to recognize that different people make different choices and if they are appropriately informed, I don’t think we should remove that option,” she added, explaining her vote.
The CDC called the vote in light of concerning new safety data.
At least nine people have died from clotting with low platelets or Thrombosis with Thrombocytopenia Syndrome (TTS) as of December 9, with around 16 million doses of the vaccine administered, according to new data released by the CDC.
There were 54 cases as of August 31, and 36 required admission to intensive care. Some of those who did not die had long-term effects such as paralysis.
The greatest risks were seen in women aged 30-49, where the rate of TTS was around one in 100,000.
But the risk is not confined to this demographic, with two of the nine deaths occurring among men. The CDC said the fatality count may also be an underestimate.
Overall, approximately one out of seven cases of TTS have been fatal. Similar cases have been linked to the AstraZeneca vaccine, which is authorized outside the United States and is based on the same viral vector technology.
CDC scientist Sara Oliver told a committee of independent experts there were several options available to them, including voting to recommend against using the vaccine altogether.
The Pfizer and Moderna vaccines carry risks too, the CDC said in its discussion of risks and benefits, particularly for younger men who may in very rare cases develop myocarditis or pericarditis – inflammation of or around the heart.
However, none of these cases have been fatal, and the two vaccines confer much higher protection than the J&J shot.
The panel also agreed with the company that recommending against the J&J shot entirely would send a negative signal to other parts of the world where it may be the only option available.
“The Johnson and Johnson COVID-19 vaccine is a life saving tool for individuals in high risk populations,” Penny Heaton, global therapeutic area head of vaccines at J&J argued.
As vaccine availability increases and willing adults get vaccinated, achieving herd immunity increasingly requires understanding the attitudes of those who are hesitant and the factors that shift their attitudes and behaviors – even inadvertently. Our analysis suggests that the CDC and Food and Drug Administration (FDA) recommendation on the J&J vaccine suspension was not associated with an increase in hesitancy overall, but could have had an impact on how individuals rationalize their vaccine hesitancy. Specifically, among those expressing vaccine hesitancy, we observed a significant increase in the likelihood of people being concerned about the side effects of COVID-19 vaccines.
Our findings align with an ongoing Kaiser Family Foundation (KFF) survey tracking the public’s attitudes and experiences with COVID-19 vaccinations, which recently found a decrease in vaccine hesitancy among the US adult population over time, as well as a decreasing and yet relatively stable trend for strong hesitancy .
Similarly, their results also suggest that news on blood-clots possibly related to the J&J vaccine did not significantly slow the vaccine uptake but may have increased the proportion of those concerned about side effects among those who were not vaccinated, especially among women.
Our analysis has several limitations. First, we only had one round of post-suspension data and thus cannot evaluate potential long-term impacts on hesitancy and uptake. Second, we did not have data to examine vaccine attitudes towards the different types of vaccines in the US: J&J, Moderna, and Pfizer.
The third caveat relates to a change in the HPS survey instrument in the pre- and post-suspension periods. Prior to the suspension, survey respondents were given four options (“definitely yes”, “probably yes”, “probably no”, “definitely no” when prompted whether they would receive the vaccine. An additional category “unsure” was added to the instrument used after the J&J suspension. While this did not affect our two primary measures of hesitancy and strong hesitancy, we were not able to explore more subtle shifts of different levels of vaccine hesitancy among those who were in the middle of the hesitancy spectrum.
Our findings shed light on the potential impact of recommendations from US health authorities on vaccine hesitancy, which have several implications for effective policy and related communications. As shown in our results, the suspension may have played a role in increasing concerns about COVID-19 vaccine safety among the already hesitant population.
This emphasizes the importance of using trusted channels to disseminate messages that address safety-specific concerns among those hesitant to receive the vaccine. At the same time, it is encouraging to see that precautionary communication from the US health authorities on vaccine side effects did not increase the size of the vaccine hesitant population, in aggregate. It is important to note that there were other vaccines available in the US when the CDC and FDA issued the recommendation for J&J vaccine suspension.
This decision and the news about the J&J vaccine may simply have shifted public preference for Moderna and Pfizer vaccines without decreasing the overall demand of COVID-19 vaccine. The aforementioned KFF survey also showed that after the J&J suspension, people were less confident of the safety of the J&J vaccine compared to the Pfizer and Moderna vaccines , and the possibility that this affected brand preference should be investigated with additional data in future studies.
It is unclear how the suspension would have affected the overall COVID-19 vaccine rollout if the J&J vaccine was the only vaccine available, but plausibly there may have been a more direct negative effect. This suggests there may be a benefit to having multiple vaccines available from a hesitancy perspective, as well as an operational one.
Understanding the impact of pauses like the J&J vaccine suspension is important for the US and globally, as such pauses are an important piece of the safety system in place for vaccine roll-out. Our results suggest that developing anticipatory communication strategies that focus on overall vaccine safety, and supporting vaccine research and development to have more than one vaccine options in face of an ongoing pandemic may be especially important for effective vaccine roll-out.
reference link: https://www.sciencedirect.com/science/article/pii/S0264410X21015590?via%3Dihub