UP­DAT­ED: J&J vac­ci­na­tions re­sume as FDA, CDC con­fi­dent in ben­e­fit-risk pro­file

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.

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.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

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.”

Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

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Robert Califf (Michael Brochstein/Sipa USA via AP Images)

House Re­pub­li­cans at­tack Chi­na-on­ly da­ta in FDA sub­mis­sions, seek new in­ves­ti­ga­tion in­to re­search in­spec­tions

Three Republican representatives are calling on the FDA to take a closer look at the applications including only clinical data from China.

The letter to FDA commissioner Rob Califf late last week comes as the agency recently rejected Eli Lilly’s anti-PD-1 antibody, which attempted to bring China-only data but ran into a bruising adcomm that may crush the hopes of any other companies looking to bring cheaper follow-ons based only on Chinese data.

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Janet Woodcock (Greg Nash/Pool via AP Images)

'I re­al­ly don’t look back': Janet Wood­cock on her tran­si­tion away from drugs

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.”

Özlem Türeci, BioNTech co-founder and Uğur Şahin, BioNTech CEO

Third dose bumps up ef­fi­ca­cy of Pfiz­er-BioN­Tech's Covid-19 vac­cine in youngest group of chil­dren to 80%

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.”

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Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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Adar Poonawalla, Serum Institute of India CEO (Dhiraj Singh/Bloomberg via Getty Images)

Covid-19 roundup: Serum In­sti­tute eyes Africa for glob­al ex­pan­sion — re­port; Jun­shi an­tivi­ral hits pri­ma­ry end­point in late-stage tri­al

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.

Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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