The FDA and CDC on Fri­day evening lift­ed the pause on J&J vac­ci­na­tions af­ter de­cid­ing that a very rare but some­times fa­tal side ef­fect does not change the fact that the vac­cine’s known and po­ten­tial ben­e­fits still out­weigh the risks.

FDA al­so up­dat­ed the fact sheets for vac­cine re­cip­i­ents and providers to note the risk of blood clots and low lev­els of platelets, known as throm­bo­sis with throm­bo­cy­tope­nia syn­drome (TTS).

“Most cas­es of throm­bo­sis with throm­bo­cy­tope­nia re­port­ed fol­low­ing the Janssen COVID-19 Vac­cine have oc­curred in fe­males ages 18 through 49 years; some have been fa­tal,” a sec­tion on page three of the 24-page fact sheet for health providers says. FDA added a sim­i­lar line to the up­dat­ed fact sheet for re­cip­i­ents and care­givers, al­though in this up­date, the agency did not men­tion that the side ef­fect could be fa­tal.

Some pub­lic health of­fi­cials raised con­cerns over the week­end that US of­fi­cials were down­play­ing the risks.

I re­spect @NI­HDi­rec­tor very much. How­ev­er, I dis­agree with him strong­ly @Meet­The­P­ress.

The risk in women <50 of TTS (the se­vere clot­ting dis­or­der) af­ter J&J is 1:80,000. This is low, but not the same risk of light­en­ing strik­ing. What's more, mR­NA vac­cines do not car­ry this risk. https://t.co/BKj4gT5vEi

— Leana Wen, M.D. (@Dr­LeanaWen) April 25, 2021

The de­ci­sion to restart the vac­ci­na­tions fol­lows a CDC ad­vi­so­ry com­mit­tee’s vote ear­li­er Fri­day that made the same rec­om­men­da­tion and stopped short of re­strict­ing its use for spe­cif­ic pop­u­la­tions.

J&J and FDA worked out the de­tails of the warn­ing ear­li­er in the day, ac­cord­ing to J&J’s pre­sen­ta­tion Fri­day, and J&J cau­tioned the com­mit­tee against re­strict­ing use of the vac­cine.

The CDC said Fri­day that it has now spot­ted 15 cas­es of TTS, among about 8 mil­lion re­ceiv­ing the vac­cine. Those 15 cas­es in­clude three deaths (up from one death from last week), sev­en peo­ple hos­pi­tal­ized, four of whom are in in­ten­sive care, and five peo­ple dis­charged.

Tom Shimabukuro, deputy di­rec­tor of the CDC’s Im­mu­niza­tion Safe­ty Of­fice, al­so not­ed about 10 oth­er pos­si­ble cas­es of TTS are un­der in­ves­ti­ga­tion.

The fea­tures of TTS ap­pear sim­i­lar to what is be­ing ob­served in rare in­stances fol­low­ing the As­traZeneca Covid-19 vac­cine in Eu­rope, Shimabukuro added, echo­ing com­ments made ear­li­er this week when the Eu­ro­pean Med­i­cines Agency added a warn­ing to its J&J Covid vac­cine la­bel due to TTS.

But un­like the EU, the US cur­rent­ly has plen­ti­ful and avail­able quan­ti­ties of both of the mR­NA vac­cines from Mod­er­na and Pfiz­er, which may change the ben­e­fit-risk sce­nario for J&J vac­cines in the US.

CDC mod­el­ing on Fri­day showed that even if the FDA restart­ed vac­ci­na­tions with the J&J shot in all age cat­e­gories im­me­di­ate­ly, the avail­able dos­es would on­ly speed up US vac­ci­na­tions for all in­tend­ing to do so by about two weeks (from 74 days to 88 days af­ter Fri­day).

But physi­cians at the meet­ing al­so not­ed the im­por­tance of hav­ing a sin­gle-shot vac­cine in their ar­ma­men­tar­i­um for unique pop­u­la­tions like those who are home­less, home-bound or mi­grant and sea­son­al com­mu­ni­ties.

Now that the US is swimming in Covid-19 vaccines and the supply has officially eclipsed the demand, it’s time for America to lead the world and start shipping these excess doses to countries that desperately need them.

Unlike the IP waiver at the World Trade Organization, which Biden now supports and will likely take years to translate into actual shots in arms, the US could easily donate just a tiny fraction of the more than 60 million doses of Pfizer, Moderna and J&J vaccines sitting on American shelves right now.

A Florida woman has been indicted as part of a clinical trial fraud scheme over a GlaxoSmithKline pediatric asthma study, the Justice Department announced Tuesday, the latest development in a case where three individuals have already pleaded guilty.

Jessica Palacio was charged with participating in a plot to falsify medical records, giving off the appearance that trial participants were making their scheduled visits to a Miami CRO and taking an experimental asthma medication as required. Palacio was also charged with lying to FDA investigators about her conduct.

Pfizer CEO Albert Bourla has inked a deal with Harper Business for a book to tell the “behind-the-scenes” story of the company’s race to develop a vaccine, the Associated Press reports.

The book is titled “Moonshot: Inside Pfizer’s Nine-Month Race to Make the Impossible Possible” and is set to be released Nov. 9. Bourla plans to donate the proceeds to charity, the AP reported.