You’re on your own. That seems to be the message that Pfizer and Moderna delivered to Johnson & Johnson when it approached the two companies about speaking “with one voice about safety,” according to a story in the Wall Street Journal on Friday (April 16).
Citing unnamed sources, the newspaper reported that J & J “sought to build an informal alliance to communicate the benefits and risks of the shots and address any concerns raised among the public by the blood-clot cases.” Six women have developed blood clots after receiving the J & J vaccine and one died. Pfizer and Moderna declined the invite, saying that they didn’t want to duplicate the efforts of regulators, according to the newspaper. AstraZeneca, whose vaccine has also been associated with blood clots, was interested, according to the Journal.
It never seemed like the coronavirus was going to be a one-and-done, but now the reality is setting in, especially with the emergent of variants. “The COVID virus looks more like the influenza virus than the polio virus,” Pfizer CEO Albert Bourla said during a video program produced by CVS Health that was posted on Thursday (April 15). With CVS Health CEO Karen Lynch and CNBC correspondent Bertha Coombs listening, Bourla went on to talk about the likelihood of the need for a third dose of the two-dose Pfizer vaccine and annual shots thereafter. “A likely scenario is that there will likely be a need for a third dose somewhere between six and 12 months and then from there an annual re-vaccination, he said, adding though that “all of that needs to be confirmed.”
Bourla’s prediction got some pushback. “How can Albert Bourla and Pfizer say we will need booster shots when their own vaccine data and Moderna tx’s at 6 months look very solid, and there are no data to how mRNA vaccine’s lack of protection against any variant,” tweeted Eric Topol.
There was whiff of a problem last week the European Medicine Agency said it was reviewing a “safety signal” about the single-dose J & J vaccine and a possible association with blood clots. This week that whiff got a whole lot stronger, although the Twittersphere was full of commentary that the pause on the vaccine would do more harm (possibly resulting in more COVID-19 cases) than good (maintaining public confidence in vaccine safety regulation and possibly avoiding a very slight risk of blood clots — if the vaccine is, in fact, associated with them).
And this week’s news about a possible link to blood clots came after last week’s quality problems: It’s been a bumpy ride for the J & J vaccine
The story started to unfold on Tuesday (April 13) when the FDA’s Peter Marks, M.D., and the CDC’s Anne Schuchat, M.D., issued a statement said that “out of an abundance of caution” they were recommending a “a pause in the use of this (the J&J) vaccine.” They mentioned six reported U.S. cases of cerebral venous sinus thrombosis occurring among people after they received the J&J vaccine; all six were women between the ages of 18 and 48. Cerebral venous sinus thrombosis is a rare (perhaps about 5,000 cases a year in the U.S.) type of stroke caused by blood clots blocking blood drainage through cerebral veins and sinuses of the dural mater. Marks and Schuchat also noted the denominator of more than 6.8 million doses of the vaccine that have been administered in the U. S. “Right now, these adverse events appear to be extremely rare,” said their statement. “COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously.
J&J issued a statement the same day that it had “proactively delayed” rollout of its vaccine in Europe and paused clinical trials testing the vaccine.
Then the CDC’s Advisory Committee on Immunization Practices (ACIP) swung into...inaction. The ACIP is a group of outside experts that formulate vaccine recommendations — they are only recommendations, although they are often followed by the CDCand others. The committee held an emergency meeting on Wednesday (April 14) but put off a making a decision. Some more details emerged during that meeting, including the possibility of seventh case. The CDC has scheduled a meeting of the ACIP for this coming Friday, April 23, starting at 11 a.m. to further discuss the J&J vaccine and presumably arrive at some recommendations.
Ashish Jha, M.D., M.P.H., dean of Brown University’s School of Public Health, was among those that took to Twitter to criticize the committee for delaying a decision. “ACIP should have recommended continuing pause for women 18-49 but resuming for everyone else. Keeping vaccine paused for everyone makes little sense. Risk-benefit keeping vaccine paused for everyone WAY off,” he said in a thread on Wednesday (April 14).
As of Friday (April 16) at 6 a.m., vaccine data reported to the CDC showed 202,282,923 vaccine doses administered, an increase of 23,445,142 increase, or 13%, over last Friday (April 9). The CDC’s tally shows that 127,743,096 individuals have received at least one dose of a vaccine, an increase of 13,307,057, or 11.6%, from last Friday. As of yesterday, the CDC’s numbers show 38.5% of the U.S. population has received at least one dose of a vaccine and 24.3% is fully vaccinated.
The foundation, which has been tracking public opinion about COVID-19 vaccines since December, said it was too soon to tell what the effect of the pause on the J&J vaccine in an update published on Friday (April 16). Public confidence in the vaccines has increased, the update said, but with a “small but persistent group opposed to getting the vaccine and many others still on the fence, the U.S. may soon hit a point where vaccine supply exceeds demand, a situation that is already the case in certain communities.”
The update took issue with “media narratives” that have focused on certain groups being vaccine hesitant. Yes, a greater share of people who identify as Republicans say they don’t intend to get vaccinated and more Black adults have a “wait and see” attitude. But the foundation says its research shows that a majority across all demographics are “at least somewhat open to getting the vaccine.”
Disproportionality has been a theme of the pandemic, and incarcerated people are among the groups that have been affected more than others. According to the COVID Prison Project, 2,443 incarcerated people in the U.S. have died from COVID-1 as of yesterday (April 16) and 162 members of prison staffs have perished. In a Health Affairs blog post on Thursday (April 15), Lauren Brinkley-Rubinstein, Ph.D., a co-founder of the COVID Prison Project, and her co-authors said project had counted 137, 064 people incarcerated in state or federal prisons who have received at least one vaccination as of April 1, which would work out to be about 6% of the estimated 2.2 million incarcerated people in the country.
Six patients among 491 with autoimmune inflammatory rheumatic diseases (AIIRD) developed shingles after being vaccinated with the Pfizer vaccine compared to none among 99 controls, Israeli researchers reported in the journal Rheumatology on Monday (April 6). Four of the patients who developed shingles had rheumatoid arthritis, one had Sjogren’s syndrome and one, undifferentiated connective disease. The cases of shingles were mild, they reported, except for one that involved herpes zoster ophthalmicus in a patient with rheumatoid arthritis that was being treated with Xeljanz (tofacitinib).
“To date there is no data available on the safety of mRNA COVID-19 vaccination in AIIRD (autoimmune inflammatory rheumatic disease) patient as immunosuppressed patients were excluded from the vaccines’ trials,” wrote Victoria Furer, M.D., and her colleagues. "Therefore safety and monitoring of vaccinated patients is especially warranted in this population.”
The New England Journal of Medicine published a third study on Thursday (April 16) looking into vaccine-induced immune thrombotic thrombocytopenia (VITT) after the AstraZeneca vaccine. In this study, 21 of the 23 patients had high levels of antibodies to platelet factor 4 (PF4) a phenomenon seen in the relatively rare instances when people develop blood clots in reaction to heparin, known as heparin induced thrombocytopenia. Heparin is given to prevent blood clots, so HIT is the exact opposite of the intended effect. Lead author Marie Scully, M.D., and her colleagues said the evidence so far does not show heparin would aggravate the VITT. Even so, they recommend using a nonheparin anticoagulant, such as argatroban, danaparoid, among others.
The other two NEJM studies have also implicated antibodies to PF4 as possibly playing a role in VITT. An accompanying editorial warned, though, against jumping the gun and settling on them as culprits. The understanding of the pathogenesis of VITT is incomplete, wrote wrote Douglas Cines and James Bussel, and the usefulness of measuring pathogenic anti-PF4–related antibodies in vaccine recipients has not been established: “To close the loop, the next step should be a direct demonstration that the anti-PF4 antibodies described here cause thrombosis and thrombocytopenia in an in vivo model.”
And, as many others have, Cines and Bussel also emphasized that VITT is rare and the benefits of vaccination have to be weighed against the risks. At the same time, they also left the door ajar to some vaccines perhaps being more suitable for some populations than others and the need to monitor for rare compliations.
SARS-CoV-2 didn’t surprise coronavirus experts. It’s just one variety of a slew of coronavirus, and it’s a safe bet that another will mutate in such a way as to become transmissible among humans. Jon Cohen, an award-winning science journalist for Science, wrote this week about early-days research efforts to develop a “pancoronavirus” vaccine that would immunize humans against emerging coronavirus.
“Beyond bats, coronaviruses infect camels, birds, cats, horses, mink, pigs, rabbits, pangolins, and other animals from which they could jump into human populations with little to no immunity, as most researchers suspect SARS-CoV-2 did,” wrote Cohen in a piece published on Thursday (April 15).
Although cool to the idea in the past, the National Institute of Allergy and Infectious Diseases (NIAID) has solicited applications for “emergency awards” to pursue pancoronavirus vaccine development, reported Cohen. An international nonprofit, the Coalition for Epidemic Preparedness Innovations, is also funding research, according to Cohen.