FDA's vac­cine ad­comm unan­i­mous­ly sup­ports Mod­er­na's boost­er in same pop­u­la­tions as Pfiz­er's boost­er

The FDA’s vac­cine ad­vi­so­ry com­mit­tee on Thurs­day vot­ed 19-0 in sup­port of ex­pand­ing Mod­er­na’s Covid-19 vac­cine EUA for boost­er dos­es for cer­tain high-risk in­di­vid­u­als. FDA is ex­pect­ed to au­tho­rize the Mod­er­na boost­er short­ly.

Sim­i­lar­ly to the Pfiz­er boost­er shot, Mod­er­na’s will like­ly be au­tho­rized for those old­er than 65, adults at high risk of se­vere Covid-19, and adults whose fre­quent in­sti­tu­tion­al or oc­cu­pa­tion­al ex­po­sure to SARS-CoV-2 puts them at high risk of se­ri­ous com­pli­ca­tions of Covid-19. But un­like the Pfiz­er ad­comm, where FDA had to scram­ble to get the com­mit­tee to vote in fa­vor of a boost­er, this com­mit­tee was unan­i­mous with the Mod­er­na shot.

Is­raeli sci­en­tists once again pre­sent­ed the lat­est in their ex­pe­ri­ence with boost­ers, which showed re­duced Covid-19 cas­es. Sev­er­al pan­elists praised how com­pelling the Is­raeli da­ta pre­sent­ed were.

Paul Of­fit

Paul Of­fit, a VRB­PAC pan­elist and pro­fes­sor of pe­di­atrics at Chil­dren’s Hos­pi­tal of Philadel­phia, called the da­ta clear for 70- to 79-year-olds, but said he was less im­pressed with the da­ta for those who are younger.

Oth­ers al­so ques­tioned the da­ta be­hind the boost­er, par­tic­u­lar­ly as for Mod­er­na is ap­ply­ing to ad­min­is­ter a half-dose of what was pro­vid­ed in the pri­ma­ry, two-shot se­ries.

“The da­ta we have is on­ly lim­it­ed to about 149 pa­tients on Mod­er­na. So I have some hes­i­ta­tion,” VRB­PAC mem­ber Jean­nette Lee, a pro­fes­sor of bio­sta­tis­tics at the Uni­ver­si­ty of Arkansas for Med­ical Sci­ences, said.

Pan­elist Er­ic Ru­bin, ed­i­tor in chief of the New Eng­land Jour­nal of Med­i­cine and an ex­pert on in­fec­tious dis­eases at Har­vard’s pub­lic health school, not­ed “the da­ta are not per­fect,” but these are “ex­tra­or­di­nary times.” He al­so re­it­er­at­ed the idea that the over­all ef­fect of a boost­er is much less than pri­ma­ry vac­cines, both here and abroad.

“We need to vac­ci­nate the un­vac­ci­nat­ed,” Ru­bin said.

Oth­er mem­bers of the com­mit­tee ex­plained how the Mod­er­na boost­er needs to win EUA as it wouldn’t make sense as a prac­ti­cal mat­ter to have a Pfiz­er boost­er and not one for Mod­er­na.

Pe­ter Marks

FDA’s top vac­cine leader Pe­ter Marks of­fered a sim­i­lar sen­ti­ment in not­ing that the CDC’s com­mit­tee, which is like­ly next up to re­view the Mod­er­na boost­er, may de­cide to fur­ther ma­nip­u­late the rec­om­men­da­tions from VRB­PAC, “but to the ex­tent that we can come to place that’ll be ac­cept­able for ACIP, that’ll be ap­pre­ci­at­ed.”

VRB­PAC pan­elist Steven Pergam, an ex­pert on in­fec­tious dis­eases at the Fred Hutchin­son Can­cer Re­search Cen­ter in Seat­tle, said he is “very sup­port­ive” of those with oc­cu­pa­tion­al Covid-19 risks re­ceiv­ing the boost­er, par­tic­u­lar­ly as the US seeks to pro­tect health in­sti­tu­tions from out­breaks.

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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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.

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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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.