When the CDC’s top ad­vi­so­ry com­mit­tee met last week to re­view whether a hand­ful of very rare but po­ten­tial­ly fa­tal blood clots with low platelets might be linked to J&J’s Covid-19 vac­cine, the as­sump­tion was that the com­mit­tee would, at the very least, fol­low its own agen­da and vote on whether to wait for more da­ta, or make in­ter­im age- or risk-based rec­om­men­da­tions for the vac­cine.

In­stead, the com­mit­tee did nei­ther, punt­ing its vote un­til this Fri­day when it can hold a longer dis­cus­sion with the lat­est da­ta. None of the ACIP mem­bers raised ma­jor con­cerns with the de­ci­sion, or lack there­of, de­spite some calls to not pause the vac­cine in­def­i­nite­ly.

But the in­ac­tion al­so raised con­cerns about whether the CDC and FDA were shirk­ing their re­spon­si­bil­i­ties and un­nec­es­sar­i­ly de­lay­ing J&J vac­ci­na­tions as the race to slow the spread of the coro­n­avirus con­tin­ues.

In con­trast, the Eu­ro­pean Med­i­cines Agency’s safe­ty com­mit­tee quick­ly con­clud­ed its re­view of the blood clots and the J&J vac­cine on Tues­day, de­cid­ing the vac­cine’s ben­e­fits out­weigh the risks, while adding a warn­ing to the vac­cine’s la­bel, even as no one in Eu­rope has re­ceived the vac­cine yet. Fol­low­ing the com­mit­tee’s an­nounce­ment, J&J said it would re­sume ship­ments of the vac­cine.

At first blush, the EMA, which just went through a sim­i­lar re­view with As­traZeneca’s vac­cine and came to a sim­i­lar con­clu­sion, seems to have been the more proac­tive reg­u­la­tor. The EMA made a quick de­ci­sion on the avail­able da­ta and re-start­ed the process for get­ting more shots in­to arms.

But be­yond the head­line and fi­nal de­ci­sion lies a very dif­fer­ent sto­ry.

In the case of the CDC’s com­mit­tee, any mem­ber of the pub­lic (any­where in the world) could turn on a com­put­er and watch the pro­ceed­ings, lis­ten to the se­ri­ous­ness of the de­tails, hear the ar­gu­ments and see the slides that each of the com­mit­tee mem­bers re­view. The pub­lic even has an op­por­tu­ni­ty to weigh in at the CDC meet­ing, al­though it’s un­clear how those com­ments are ac­tu­al­ly used.

The ACIP de­ci­sion to de­lay ac­tion and wait for more da­ta on the blood clots may seem like an al­most neg­li­gent re­sponse, es­pe­cial­ly giv­en the EMA’s snap de­ci­sion, when time is of the essence. But the risk cal­cu­la­tions for the two re­gions are very dif­fer­ent. The US has more of the Pfiz­er and Mod­er­na Covid vac­cines than the EU to fill the gap left by the J&J pause. The US al­so has about 10 mil­lion dos­es of the J&J vac­cine wait­ing on shelves so if the FDA and CDC of­fer a green­light, those dos­es will im­me­di­ate­ly be ad­min­is­tered.

Al­so, the EMA’s safe­ty com­mit­tee com­plet­ed its analy­sis of the J&J and As­traZeneca vac­cine da­ta be­hind closed doors, on­ly of­fer­ing a peek in­to what oc­curred via lim­it­ed press re­leas­es and press con­fer­ences that usu­al­ly lead to as many new ques­tions as an­swers.

Pe­ter Ar­lett

For in­stance, at each of the EMA press con­fer­ences on the vac­cine la­bel up­dates, Pe­ter Ar­lett, the head of phar­ma­covig­i­lance at the EMA, has un­veiled new fig­ures on the cas­es of blood clots with low platelets for each of the vac­cines au­tho­rized in the EU.

But in do­ing so, Ar­lett fails to of­fer any fur­ther in­for­ma­tion on how many to­tal dos­es of the vac­cines have been ad­min­is­tered or where these new cas­es oc­curred. At least twice now, ei­ther Ar­lett or some­one else at the EMA has had to cor­rect or clar­i­fy what the num­bers mean, or where the cas­es did or did not oc­cur.

If the EMA is go­ing to re­lease these num­bers, why not put them in a press re­lease and ful­ly ex­plain them? In­stead, the agency leaves it to the pub­lic to de­cide on what they might mean, which is con­cern­ing as they are not ap­ples-to-ap­ples com­par­isons. Pfiz­er see­ing 25 cas­es of the blood clots and low platelets ver­sus J&J see­ing 8 cas­es are not com­pa­ra­ble con­sid­er­ing how many tens of mil­lions of more dos­es of the Pfiz­er vac­cine have been ad­min­is­tered.

In oth­er in­stances (e.g. re­leas­ing clin­i­cal tri­al re­sults), the EMA has tak­en a lead­ing role in show­ing the world how trans­paren­cy works. But in this case, even with the FDA and CDC tak­ing ex­tra days to make its de­ci­sion, and even if the de­ci­sion is to re­strict the use of the J&J vac­cine to a spe­cif­ic pop­u­la­tion, the im­por­tance of trans­paren­cy is clear.

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

The Biden administration’s goal of kicking off its booster shot drive for the entire US population this week is not quite going as planned.

First, Pfizer applied for approval of a supplemental application for the booster shots, but since last Friday’s adcomm reviewing them, the plan has devolved into an EUA, which the FDA issued late Thursday evening.

The population that is now eligible for the booster, six months after receiving the first pair of Pfizer-BioNTech vaccines, also narrowed from what Pfizer applied for (everyone who’s eligible for the initial Pfizer shots) to just those who are 65 or older, or at high-risk of a Covid infection, including health care workers and others with occupational hazards.

A final look at the results of the placebo-controlled Moderna trial in the New England Journal of Medicine, published Thursday afternoon, shows how the vaccine continues to prevent Covid-19 and severe cases after more than five months following the second shot.

Of the more than 30,000 enrolled in the trial that ultimately led to the vaccine’s EUA, only two people in the vaccine group got a severe form of the disease, compared to 106 in the placebo group — leading to an efficacy of 98%.

Bluebell Capital Partners, a proxy brawler fresh off a campaign to oust global food giant Danone’s CEO and most of its board of directors, has bought a stake in UK drugmaker GlaxoSmithKline with its eyes trained directly on Emma Walmsley, the Financial Times reported Wednesday.

The London-based hedge fund joins another notorious activist firm in Paul Singer’s Elliott Management, which earlier this year called for a shakeup in leadership at GSK to handle what the company described as a wealth of riches across the drug giant’s portfolio hindered by limited vision from top staff.