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.

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

UP­DAT­ED: Gink­go Bioworks re­sizes the de­f­i­n­i­tion of go­ing big in biotech, rais­ing $2.5B in a record SPAC deal that weighs in with a whop­ping $15B-plus val­u­a­tion

Ginkgo Bioworks execs always thought big. But today should redefine just how big an upstart biotech player can dream.

In the largest SPAC deal to clear the hurdles to Nasdaq, the biotech that envisioned everything from remaking synthetic meat to a whole new approach to developing drugs has joined forces with one of the biggest disruptors in biotech to slam the Richter scale on dealmaking.

Soon after becoming the darling of the VC crew and clearing the bar on a $4 billion valuation, Ginkgo — a synthetic biotech player out to reprogram cells with industrial efficiency — has now struck a deal to go public in the latest leviathan SPAC that sets its pre-money valuation at $15 billion. In one swift vault, Ginkgo will combine with Harry Sloan’s Soaring Eagle Acquisition Corp. and leap into the public markets.

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FDA un­veils six ICH guide­lines ahead of meet­ing with Health Cana­da

A sign that the FDA’s non-Covid-related processes are beginning to normalize: The release of six guidelines from the International Council of Harmonisation.

Years in development, the ICH documents offer an international perspective on drug development, with these latest guidelines covering everything from recommendations to support the classification of drug substances, featured in the M9 guidance, to standards for nonclinical safety studies for pediatric medicines in the S11 guideline.

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A clos­er look at the FDA’s more than 700 pan­dem­ic-re­lat­ed record re­quests to re­place on­site in­spec­tions

As the pandemic constrained the FDA’s ability to travel for onsite manufacturing inspections, the agency increasingly turned to requesting records to fill the gap, even for hundreds of US-based facilities.

FDA explains in its guidance on manufacturing inspections during the pandemic that the agency can request records (not to be confused with the FDA’s remote interactive evaluations) directly from facilities “in advance of or in lieu of” certain onsite inspections. Companies are legally required to fulfill those requests because a denial may be considered limiting an inspection, which could lead to the FDA deeming a drug made at that site to be adulterated.

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Sanofi, Glax­o­SmithK­line, Boehringer ac­cused of play­ing games, de­stroy­ing emails re­lat­ed to law­suit over con­t­a­m­i­nat­ed Zan­tac

A recent court filing raises new questions about how major pharma companies like Sanofi, GlaxoSmithKline, and Boehringer Ingelheim have dealt with a lawsuit related to recalls of certain over-the-counter heartburn drugs due to the presence of a potentially cancer-causing substance found in them.

More than 70,000 people who took Sanofi’s Zantac and other heartburn drugs containing ranitidine, which have been recalled over the past two years, have sued the manufacturers, including generic drugmakers, and other retailers and distributors as part of a consolidated suit before US District Court Judge Robin Rosenberg in Florida.

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Distribution of Moderna's Covid-19 Vaccine (Photo by Paul Sancya - Pool/Getty Images)

Opin­ion: Ado­les­cents can wait. The US needs to start do­nat­ing Covid-19 vac­cines to needy coun­tries now.

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.

UP­DAT­ED: Feds charge an­oth­er CRO staffer with fak­ing da­ta in a Glax­o­SmithK­line pe­di­atric asth­ma study

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.

Albert Bourla, Pfizer CEO (Gian Ehrenzeller/Keystone via AP Images)

Covid-19 roundup: Pfiz­er CEO Bourla to write book about vac­cine arms race; Chi­nese mR­NA shot set for PhI­II tri­al in Mex­i­co

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.

Chris Garabedian (Xontogeny)

Per­cep­tive Ad­vi­sors, Xon­toge­ny bring the band back and then some with a $515M sec­ond fund sniff­ing out lead com­pounds

When Perceptive Advisors and startup accelerator Xontogeny initially teamed up on an early-stage VC round in 2019, the partners hoped to prove their investments could be a force multiplier for early-stage companies. Now, with that proof of concept behind them, the pair have closed a second VC round worth more than double the money.

Dubbed PXV Fund II and headed by Xontogeny CEO and former Sarepta head Chris Garabedian, the $515 million fund will target 10 to 12 early-stage preclinical companies with Series A rounds in the $20 million to $40 million range with opportunities for Series B follow-ups. The oversubscribed fund is bringing the band back with initial investors from PXVI as well as new investors that include “top-tier” asset managers, endowments, foundations, family offices, and individual investors.

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