Europeans are investigating “safety signal” of blood clots, J&J vax

The AstraZeneca vaccine has gotten a lot of unwanted attention this week because of a possible association with blood clots. But on Friday (April 9) the safety committee of the European Medicines Agency (the European equivalent of the FDA) announced that it was reviewing a “safety signal” about the Johnson & Johnson vaccine and blood clots.

The committee, known formally as Pharmacovigilance Risk Assessment Committee, said four serious cases of unusual blood clots with low blood platelets have occurred in people they have vaccinated with the J&J vaccine, one during a clinical trial and three during the vaccine rollout in the U.S. The European drug regulator defines a safety signal as a “new or known adverse event that is potentially caused by a medicine and that warrants further investigation.” The J & J vaccine has been approved for use in Europe but hasn’t been administered in countries there yet.

The Wall Street Journal reported that the company’s response was that close tracking of side effects had revealed a small number of rare event but that “at present, no clear causal relationship has been established between these rare events and the Janssen Covid-19 vaccine.”

Uh-oh, vaccination rate likely to plateau

Right now, demand for vaccines is exceeding supply. But that may soon flip — and that spells big trouble for achieving the 70% to 90% vaccine coverage that’s needed to achieve herd immunity, according to a Surgo Venture analysis of a survey about American attitudes about COVID-19 vaccination that the company issued on Thursday (April 8).

(Many thanks to Caitlin Owens at Axios Vitals for drawing attention to the Surgo analysis in her April 9 newsletter. Owens is a must read).

Surgo, which bills itself as a behavioral science/data science/AI company, conducted a survey of 1,670 adults from March 18 through March 25 to assess people’s confidence and attitudes toward the COVID-1 vaccines. Using data from survey to add some nuance to vaccine hesitancy and current vaccination rates, Surgo reckons that most “vaccine-enthusiastic adults” will have received at least one dose of vaccine by the end of the month.

But its model shows the overall trend line flattening out by July as the proportion of the unvaccinated that holdouts increases. In other words, the supply might be there but not the demand. Surgo’s projects that a year (April 22) from now, 58% of the population (74% of adults) will be vaccinated, well shy of the herd immunity threshold.

Surgo’s survey adds some nuance to what it means to be vaccine hesitant or reluctance. The company’s press release says that 7% of the survey respondents said they wanted to wait a year before getting vaccinated, 10% were not sure when they get would get vaccinated, and 16% said they would not get vaccinated.

“To achieve vaccination of 90% of U.S., adults, we will need to convince all of the ‘don’t knows’ respondents and some of the people who currently say they won’t get the vaccine,” says Surgo.

Surgo also divided respondents into five “psychobehavioral segments”: enthusiasts, watchful, cost-anxious, system distrusters, and conspiracy believers. Compared to a survey it conducted several months ago, the March survey showed a decline in the watchful (from 20% to down to 6%) and cost anxious (14% to 9%) but little change in the system distrusters (9% to 6%) and conspiracy believers (17% to 16%)

Vaccination isn’t the only ingredient in herd immunity. Past infection is another factor, and the Surgo press release mentions the 26.7% of Americans who have had COVID-19 as helping achieve herd immunity.

178,837,781 and counting

As yesterday (April 9), data posted by the CDC show 178,837,781 vaccine doses administered and 114,436,039 people in the U.S., or 34.5% of the population, having received at least one dose of the vaccine.

Pfizer, BioNTech ask for EUA expansion to include 12–15-year-olds

After reporting positive results from a phase 3 trial in young teens, the two companies announced in a press release Friday (April 9) that they are requesting the FDA to expand the emergency use authorization for their vaccine to include adolescents, ages 12 to 15.

The companies put out a press release on March 31 announcing the phase 3 clinical trial results in young teens. According to that press release, 18 cases of COVID-19 were identified in the placebo group of 1,129 study volunteers compared with none in the vaccinated group of 1,131 volunteers.

Well that’s not good news: A big drop in the supply of J&J vax next week

A lot of the hopes for herd immunity and some kind of resumption of prepandemic activity ret on the single-dose J&J vaccine, so the news on Thursday (April 8) that the company would be sending out 700,000 doses this week, down from 4,947,500, according to information posted by the CDC on its website.

On Friday (April 9), the New York Times reported that the White House pandemic response coordinator, Jeffrey Zients, said J&J expects to deliver to be able deliver 8 million doses weekly “if a Baltimore plant making the bulk of the doses of the United States is cleared by the Food and Drug Administration.” That could be a pretty big if.

Jeffrey Zients

The “Baltimore plant” is the facility run by Emergent BioSolutions. Last week, the Times and the Washington Post reported that ingredients for the J&J and AstraZeneca vaccines were mistakenly mixed. Emergent is a contract manufacturer for both companies.

Last Saturday (April 3), J&J put out a statement saying that it was “assuming full responsibility regarding the manufacturing of drug substance for its COVID-19 vaccine” at the Emergent BioSolutions facility. The Times reported that the Biden administration put the company in charge of the facility.

Still, Zients said during a press briefing on Friday (according to a transcript posted on the White House’s website) that “Johnson & Johnson has also reiterated its commitment to provide at or near 100 million vaccine doses by the end of May.”

30k pharmacies in the fray, another 10k about to join

Pharmacies have been a major avenue for the vaccine rollout. Zients said on Friday that 30,000 pharmacies are participating in the Federal Retail Pharmacy Program and that the program was on track to hit the President Biden’ goal of 40,000 by this coming Friday (April 19).

NIAID launching study of allergic reactions to Pfizer, Moderna vaccines

There are have been scattered reports of rare but serious allergic reactions to the RNA vaccines. On Wednesday (April 7), the National Institute of Allergy and Infectious Diseases (NIAID) announced the beginning of a study designed to take a systematic look at the problem. The plan for the study, named the Systemic Allergic Reactions to SARS-CoV-2 Vacciantion, is to enroll 3,400 adults at 35 academic allergy research centers around the country, 60% of whom have a history of having had a severe allergic reaction or a diagnosis of a mast cell disorder while the remaining 40% will not. The volunteers in each of those two groups will be randomly assigned to receive the Pfizer or Moderna vaccine. There’s also to be a placebo group that gives a placebo shot followed by either the Pfizer or Moderna jab, although everyone in the study will eventually get the full two doses. Emergency medications will be on hand in case of an immediate reaction. The press release says results are expected late this summer.

“The public understandably has been concerned about the reports of rare, severe allergic reactions to the Moderna and Pfizer-BioNTech COVID-19 vaccines,” the press release quoted NIAID Director Anthony Fauci, M.D., as saying. “The information gathered during this trial will help doctors advise people who are highly allergic or have a mast cell disorder about the the risks and benefits of receiving these two vaccines.”

EMA makes it official: Blood clots are a side effect of the AstraZeneca vaccine

The association between blood clots and the AstraZeneca vaccine has been in the news. European countries have paused roll out of the vaccine, and the blood clot problem has cast some doubt on whether the future use of the vaccine in the U.S.On Wednesday (April 7), the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) said it had concluded that unusual blood clots with low blood platelet should be listed as a very rare side effect of the vaccine. At the same time, at the top of the statement posted on the website, in boldface, it says “EMA confirms overall benefit-risk remains positive.”

The PRAC statement says that the blood clots occur in veins in the brain (cerebral venous sinus thrombosis) and the abdomen (splanchnic vein thrombosis) and in arteries, together with low levels of blood platelets and sometimes bleeding. So far, the statement says, most of the cases have occurred in women under age 60 years of age and within two weeks of vaccination.

Blood clots typically involve the clumping of “sticky” platelets. The committee’s statement says one “plausible explanation” for the combination of blood clots and low blood platelets is an immune response, leading to a condition similar to one seen sometimes in patients treated with heparin (heparin induced thrombocytopenia).

The committee said its statement was based on in-depth review of 62 cases of cerebral venous sinus thrombosis and 24 cases of splanchnic vein thrombosis reported in the EU drug safety database as of March 22, 2021. Eighteen of the caseswere fatal.The cases came mainly from reporting systems I the EU and the United Kingdom, where about 25 million people have received the AstraZeneca vaccine, said the statement.

Biden opens up vaccines for all adults ages 18 and older

States have been opening up vaccine eligibility to more and more groups and back on March 11, President Joe Biden announced that he would direct states to make all adults, ages 18 and older, eligible to receive a coronavirus vaccine. On Tuesday (April 6), Biden announced that he was moving that day up to Monday, April 19. “That means by no later than April 19, in every part of this country, every adult, 18 or older, will be eligible to be vaccinated,” Biden said. “No more confusing rules. No more confusing restrictions.”

“Only hot people get the Pfizer vaccine” but Dolly got Moderna

Vaccine selfies are everywhere on social media, including TikTok, and people are having some fun playing up the Pfizer versus Moderna rivalry. The Modernians are flaunting the association with Dolly Parton, according to an NBC News story this week. Parton, who was vaccinated with the Moderna vaccine, donated $1 million to Vanderbilt University last year, and Vanderbilt researchers worked with Moderna in developing its vaccine. But the Pfizer fans are not conceding.

“Only hot people get the Pfizer,” teased a Pfizer gang TikToker. “If you got Moderna then I don’t know what to tell you, queen.”