Alex Gorsky, J&J CEO (AP Images)

Covid-19 roundup: J&J to ap­ply for boost­er au­tho­riza­tion this week as ad­comms are set; BioN­Tech CEO Ugur Sahin pre­dicts need for new vac­cine for­mu­la­tion

Two weeks af­ter re­leas­ing new da­ta show­ing its Covid-19 boost­er shot bumped pro­tec­tion against mod­er­ate to se­vere dis­ease up to 75% world­wide, J&J is re­port­ed­ly prepar­ing an ap­pli­ca­tion for the FDA.

The phar­ma is plan­ning on ask­ing US reg­u­la­tors ear­ly this week to au­tho­rize its Covid-19 boost­er shot, un­named sources told the New York Times. 

The FDA au­tho­rized Pfiz­er and BioN­Tech’s boost­er shot last month, and is re­port­ed­ly con­sid­er­ing a half-dose boost­er of Mod­er­na’s vac­cine. The agency put out word Fri­day that its Vac­cines and Re­lat­ed Bi­o­log­i­cal Prod­ucts Ad­vi­so­ry Com­mit­tee will meet on Oct. 14 and 15 to dis­cuss Mod­er­na and J&J’s boost­ers, re­spec­tive­ly.

The ad­comm will al­so hear pre­sen­ta­tions on “mix-and-match” boost­ers, or the use of a dif­fer­ent vac­cine than the one used for the pri­ma­ry se­ries. And on Oct. 26, the ad­comm will re­view an ex­pan­sion of Pfiz­er’s EUA to al­low the vac­cine’s use in chil­dren 5 through 11 years of age.

A cou­ple of weeks ago, J&J un­veiled da­ta from the Phase III EN­SEM­BLE 2 study, which looked at boost­er shots at two dif­fer­ent points in time: a sec­ond shot 56 days af­ter the first shot, or a sec­ond shot six months af­ter the first. The eight-week shot showed in­creased pro­tec­tion against mod­er­ate to se­vere Covid-19 to 75% glob­al­ly, and 94% in just the US, ac­cord­ing to the com­pa­ny.

Pro­tec­tion against se­vere Covid-19 at least 14 days post-fi­nal vac­ci­na­tion was 100%, J&J said. While the eight-week shot led to a four- to six-fold in­crease in an­ti­bod­ies, the six-month boost­er showed a nine- to twelve-fold in­crease, re­gard­less of age.

A pan­el of sci­en­tists and doc­tors who gath­ered to dis­cuss Pfiz­er’s boost­er shot a cou­ple of weeks ago sug­gest­ed that those who re­ceived J&J’s sin­gle-dose vac­cine may need boost­ers more ur­gent­ly.

“To me, the biggest pol­i­cy ques­tion out there is the John­son & John­son [boost­er],” said He­len Keipp Tal­bot at Van­der­bilt Uni­ver­si­ty, a mem­ber of the CDC’s Ad­vi­so­ry Com­mit­tee on Im­mu­niza­tion Prac­tices, per NPR. “I wor­ry we’re get­ting dis­tract­ed by the ques­tion of boost­ers of Pfiz­er when we have big­ger and more im­por­tant things to do in the pan­dem­ic.”

BioN­Tech CEO Ugur Sahin pre­dicts need for new vac­cine for­mu­la­tion

Pfiz­er CEO Al­bert Bourla pre­dict­ed a re­turn to nor­mal­cy in the US with­in a year on ABC last week — but made clear that vac­cines will be a big part of the so­lu­tion. BioN­Tech CEO Ugur Sahin re­it­er­at­ed that sen­ti­ment this week, sug­gest­ing that a new for­mu­la­tion of the com­pa­nies’ vac­cine will like­ly be nec­es­sary to tack­le new vari­ants.

Ugur Sahin

“This virus will stay, and the virus will fur­ther adapt,” Sahin told the Fi­nan­cial Times. “We have no rea­son to as­sume that the next gen­er­a­tion virus will be eas­i­er to han­dle for the im­mune sys­tem than the ex­ist­ing gen­er­a­tion. This is a con­tin­u­ous evo­lu­tion, and that evo­lu­tion has just start­ed.”

While the cur­rent for­mu­la­tion of Pfiz­er and BioN­Tech’s Covid-19 ap­pears to be suf­fi­cient against mu­ta­tions like the Delta vari­ant (the FDA au­tho­rized a third boost­er dose last month), new mu­ta­tions could emerge that evade the vac­cine’s pro­tec­tion, re­quir­ing a more “tai­lored” ver­sion of the shot, Sahin told the FT. He pre­dicts a new vac­cine could be need­ed by the mid­dle of next year.

Oth­er ex­perts have al­so sug­gest­ed that up­dat­ed vac­cines could be nec­es­sary, much like the flu shot that’s tar­get­ed each year to­ward promi­nent strains. Up­on read­ing out da­ta from its own vari­ant-spe­cif­ic boost­er can­di­date back in April, Mod­er­na CEO Stéphane Ban­cel told End­points News that high-risk in­di­vid­u­als could be look­ing at sev­er­al boosts over the course of the next two years.

“We think over time, maybe a boost per year might be enough, es­pe­cial­ly if com­bined with your flu boosts,” he said at the time.

EMA rec­om­mends Pfiz­er boost­er shot for 18+

The Eu­ro­pean Med­i­cines Agency on Mon­day rec­om­mend­ed the Pfiz­er boost­er shot at least six months af­ter the sec­ond dose for those old­er than 18. The EMA said the rec­om­men­da­tion is based on a re­view of Pfiz­er da­ta show­ing a rise in an­ti­body lev­els when a boost­er dose is giv­en ap­prox­i­mate­ly 6 months af­ter the sec­ond dose in peo­ple 18 to 55 years old.

The agency al­so rec­om­mend­ed that im­muno­com­pro­mised peo­ple can re­ceive boost­ers from ei­ther the Pfiz­er or Mod­er­na shots, at least 28 days af­ter their sec­ond dose.

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 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.

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.

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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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.

Albert Bourla (Evan Vucci, AP Images)

Covid-19 roundup: Pfiz­er/BioN­Tech say boost­er is 95.6% ef­fec­tive; Eu­ro­pean Par­lia­ment calls for more vac­cine trans­paren­cy

A month after the FDA authorized a booster dose of Pfizer and BioNTech’s Covid-19 shot for certain at-risk individuals, the companies are releasing new data that suggest the extra shot has a 95.6% efficacy compared to the two-dose series.

The results come from a Phase III trial that tested a third 30 µg dose of the vaccine given at a median of 11 months, compared to a placebo on top of Pfizer’s two-dose series. A thousand participants 16 years and older participated, just over 23% of whom were 65 or older.