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.

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

Janet Woodcock may have one of the most historically long and drug-intense tenures in FDA history, but her new role is outside of all things pharma and the once-acting FDA commissioner isn’t looking back.

“No I really don’t look back,” Woodcock told Endpoints News via email on Monday morning. “Yes I will be transitioning. Longer discussion on infrastructure needed.”

Pfizer and BioNTech said Monday that they’re ready to approach the FDA this week with early data for their booster shot for Covid-19 vaccine in the youngest age group (6 months to under 5 years), which showed 80.3% efficacy based on 10 symptomatic Covid cases identified beginning seven days after the third dose.

“The study suggests that a low 3-ug dose of our vaccine, carefully selected based on tolerability data, provides young children with a high level of protection against the recent COVID-19 strains,” Uğur Şahin, CEO and co-founder of BioNTech said in a statement. “We are preparing the relevant documents and expect completing the submission process to the FDA this week, with submissions to EMA and other regulatory agencies to follow within the coming weeks.”

After Serum Institute CEO Adar Poonawalla announced last month that the world’s largest vaccine maker stopped producing doses of Covid-19 vaccines back in December, the institute is looking to expand.

The CEO told Reuters Monday that the company is considering establishing its first manufacturing plant in Africa in its next step toward global expansion after successfully mass producing and selling hundreds of millions of Covid-19 vaccine doses out of its India-based facilities.