Covid-19 roundup: As­traZeneca vac­cine halt­ed in Ger­many for be­low-60 pop­u­la­tion; Pfiz­er says Covid-19 vac­cine has 100% ef­fi­ca­cy in chil­dren ages 12-15

Ger­many will stop us­ing As­traZeneca’s Covid-19 vac­cine on res­i­dents be­low the age of 60 due to con­cerns sur­round­ing “rare but fa­tal blood clots,” ac­cord­ing to the Wash­ing­ton Post.

Chan­cel­lor An­gela Merkel said Tues­day that the gov­ern­ment can­not ig­nore the rec­om­men­da­tion from Ger­many’s vac­cine com­mit­tee. The Paul Ehrlich In­sti­tute re­port­ed 31 cas­es of ve­nous throm­bo­sis, a brain clot that can lead to he­m­or­rhag­ing.

With ve­nous throm­bo­sis, the vein that drains blood from the brain is blocked, which can lead to dead­ly bleed­ing in the brain. The pa­tients in all 31 cas­es had low lev­els of platelets. That leads to clot­ting.

Those 31 cas­es hap­pened among the 2.7 mil­lion peo­ple in the coun­try that re­ceived As­traZeneca’s virus.

Nine peo­ple have died, the Post re­ports. Every­one who ex­pe­ri­enced the brain clot was younger than 63, and all but two of those re­port­ed cas­es were in women.

A group of clot­ting spe­cial­ists led by An­dreas Greinach­er of the Uni­ver­si­ty of Greif­swald say that the side ef­fects are sim­i­lar to those of the blood thin­ner he­parin called he­parin-in­duced throm­bo­cy­tope­nia (HIT), Sci­ence re­port­ed.

As­traZeneca’s vac­cine has been un­der scruti­ny af­ter pool­ing da­ta from dif­fer­ent and re­lease con­flict­ing ef­fi­ca­cy num­bers last fall. In some of those an­nounce­ments, the vac­cine ap­peared po­ten­tial­ly far less ef­fec­tive than the Pfiz­er/BioN­Tech and Mod­er­na’s re­ports of 95% and 94.5%.

Last week, the DSMB charged with over­see­ing the tri­al alert­ed of­fi­cials at the NIH that As­traZeneca had ig­nored its rec­om­men­da­tion to tell the pub­lic that the da­ta they were see­ing in Feb­ru­ary and March in­di­cat­ed a rate of 69% to 74%. That led NIH di­rec­tor An­tho­ny Fau­ci to go on ABC’s Good Morn­ing Amer­i­ca and call the move an “un­forced er­ror.”

“The fact is this is very like­ly a very good vac­cine,” Fau­ci said. “This kind of thing does … re­al­ly cast some doubt about the vac­cines and maybe con­tribute to the hes­i­tan­cy. It was not nec­es­sary.”

The com­pa­ny has ad­just­ed the ef­fi­ca­cy rate of its vac­cine to 76% to 79%.

Pfiz­er says Covid-19 vac­cine has 100% in chil­dren ages 12-15

A Phase III tri­al of Pfiz­er and BioN­Tech’s Covid-19 vac­cine has demon­strat­ed 100% ef­fi­ca­cy in chil­dren be­tween the ages of 12 and 15, Pfiz­er an­nounced Wednes­day. Those re­sults ex­ceed ef­fi­ca­cy num­bers record­ed ear­li­er re­port­ed in par­tic­i­pants be­tween the ages of 16 and 25 years old, the com­pa­ny stat­ed in a re­lease.

The tri­al — which con­sist­ed of 2,260 ado­les­cents be­tween the ages of 12 and 15 — saw 18 cas­es of Covid-19 ap­pear in the place­bo group, and none in the vac­ci­nat­ed group, Pfiz­er said. The com­pa­ny plans to sub­mit the da­ta for the FDA and EMA for an amend­ment to the EUA of the vac­cine.

“Across the globe, we are long­ing for a nor­mal life. This is es­pe­cial­ly true for our chil­dren,” said BioN­Tech CEO Ugur Sahin in a state­ment. “The ini­tial re­sults we have seen in the ado­les­cent stud­ies sug­gest that chil­dren are par­tic­u­lar­ly well pro­tect­ed by vac­ci­na­tion.”

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data is messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data is exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

David Lockhart, ReCode Therapeutics CEO

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

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Boost­er bo­nan­za: FDA en­dors­es 'mix-and-match' scheme, and Mod­er­na and J&J too

The FDA late Wednesday signed off on authorizing the use of heterologous — or what FDA calls a “mix and match” of a primary vaccine series and different booster doses — for all currently available Covid-19 vaccines, in addition to separately authorizing Moderna and J&J boosters.

On the mix-and-match approach, which FDA officials insisted isn’t too confusing in a press conference, the agency offered the example of an 18-year-old who received the J&J shot at least two months ago and may now receive a single booster of the J&J, a half dose of the Moderna, or the Pfizer-BioNTech booster.

Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

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Man­u­fac­tur­ing woes for No­vavax’s Covid jab bad­ly dis­rupt plans for roll­out to the poor — re­port

Production problems at a Novavax facility in Maryland have led to delays in the Covax vaccine sharing program. Now, a shortage of 1 billion doses is expected, as the supplier tries to navigate producing a shot up to regulators’ standards, Politico reported Tuesday.

The company has run into trouble with the purity of the vaccine. Novavax has had trouble proving it can produce a shot consistently up to standards, and it has caused significant delays in the rollout to low- and middle-income countries. This follows several delays at Novavax that has put the executive crew on the defensive.

Bill Gates at the Global Investment Summit in London, Oct. 19, 2021 (Leon Neal/Pool via AP Images)

Gates Foun­da­tion pledges $120M to ramp up gener­ic sup­ply of Mer­ck­'s Covid-19 pill while ac­tivists blast Pfiz­er's dis­pro­por­tion­ate pow­er

Merck’s molnupiravir may not be officially authorized anywhere in the world yet, but who will get access to it has shaped up to be a huge issue. The Bill & Melinda Gates Foundation is now stepping up to ensure lower-income countries won’t be left behind — and calling on others to follow its lead.

The oral antiviral pill, which was shown to dramatically cut the risk of severe Covid-19 disease and death in a Phase III study, is the latest rallying symbol in the battle against not just the coronavirus but the inequality it’s exposed.

Sen. Richard Durbin (D-IL, foreground) and Sen. Richard Blumenthal (D-CT) (Patrick Semansky/AP Images)

Sen­a­tors back FDA's plan to re­quire manda­to­ry pre­scriber ed­u­ca­tion for opi­oids

Three Senate Democrats are backing an FDA plan to require mandatory prescriber education for opioids as overdose deaths have risen sharply over the past decade, with almost 97,000 American opioid-related overdose deaths in the past year alone.

While acknowledging a decline in overall opioid analgesic dispensing in recent years, the FDA said it’s reconsidering the need for mandatory prescriber training through a REMS given the current situation with overdoses, and is seeking input on the aspects of the opioid crisis that mandatory training could potentially mitigate.