About a month af­ter an­nounc­ing their vari­ant-spe­cif­ic Covid-19 vac­cine boost­ers showed promis­ing re­sults in mice, Mod­er­na says it now has some hu­man da­ta to back it up.

Vol­un­teers giv­en a boost­er shot about six to eight months af­ter re­ceiv­ing their sec­ond dose saw in­creased an­ti­body lev­els against SARS-CoV-2 and two vari­ants of con­cern: B.1.351, which was first iden­ti­fied in South Africa, and P.1, first iden­ti­fied in Brazil, the com­pa­ny said on Wednes­day.

The analy­sis came from par­tic­i­pants who were giv­en ei­ther a third dose of mR­NA-1273 (the orig­i­nal vac­cine cur­rent­ly au­tho­rized in the US), or mR­NA-1273.351, a strain-matched boost­er tar­get­ing the B.1.351 vari­ant. Mod­er­na is cur­rent­ly test­ing mR­NA-1273.211 — a 50/50 com­bi­na­tion of mR­NA 1273 and mR­NA-1273.351 — in a dif­fer­ent arm of the Phase II study.

Fol­low­ing a boost of ei­ther mR­NA-1273 or mR­NA-1273.351, par­tic­i­pants’ neu­tral­iz­ing an­ti­bod­ies in­creased to lev­els sim­i­lar to or high­er than those seen against the an­ces­tral strain af­ter first vac­ci­na­tion, Mod­er­na said. Fif­teen days post-boost­er, the vari­ant-spe­cif­ic shot ap­peared to be more ef­fec­tive than the orig­i­nal vac­cine at in­creas­ing an­ti­body lev­els against the B.1.351 strain, pro­duc­ing geo­met­ric mean titer lev­els more than one-and-a-half times high­er than mR­NA-1273.

Al­so from the re­sults:

The rel­a­tive de­crease in neu­tral­iz­ing titers be­tween the wild-type (D614G) and B.1.351 as­says al­so im­proved with mR­NA-1273.351 boost­er, from a 7.7-fold dif­fer­ence pri­or to boost to a 2.6-fold dif­fer­ence 15 days af­ter  boost, sug­gest­ing a po­ten­tial­ly more bal­anced im­mune re­sponse against the test­ed vari­ants.

Safe­ty and tol­er­a­bil­i­ty da­ta were “gen­er­al­ly com­pa­ra­ble” to those seen af­ter the sec­ond dose of the orig­i­nal vac­cine in pre­vi­ous Phase II and III tri­als, Mod­er­na said. The re­sults have been sub­mit­ted as a preprint to bioRx­iv, and will be sub­mit­ted for peer-re­viewed pub­li­ca­tion af­ter Mod­er­na wraps up the mR­NA-1273.211 por­tion of the study.

“We are en­cour­aged by these new da­ta, which re­in­force our con­fi­dence that our boost­er  strat­e­gy should be pro­tec­tive against these new­ly de­tect­ed vari­ants. The strong and rapid boost in titers  to lev­els above pri­ma­ry vac­ci­na­tion al­so clear­ly demon­strates the abil­i­ty of mR­NA-1273 to in­duce im­mune mem­o­ry,” CEO Stéphane Ban­cel said in a state­ment.

Ban­cel told End­points News last month that he ex­pects the virus to mu­tate very quick­ly in the next cou­ple years, due to the fact that many peo­ple haven’t yet been vac­ci­nat­ed or in­fect­ed. He be­lieves there will be a need for sev­er­al boosts over the next cou­ple years, “es­pe­cial­ly peo­ple at high risk.” Then in 2023 or 2024, as the speed at which the vac­cine mu­tates slows down, a boost per year might be enough, he said.

“Our mR­NA plat­form  al­lows for rapid de­sign of vac­cine can­di­dates that in­cor­po­rate key virus mu­ta­tions, po­ten­tial­ly al­low­ing  for faster de­vel­op­ment of fu­ture al­ter­na­tive vari­ant-matched vac­cines should they be need­ed,” Ban­cel said Wednes­day.

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.

The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.

Sage Chemical won the first generic approval for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.

President Joe Biden yesterday signed into law a bill requiring the Office of the Director of National Intelligence to declassify information on the origins of Covid-19 within 90 days.

The new law directs the federal government to “declassify any and all information relating to potential links between the Wuhan Institute of Virology and the origin of the Coronavirus Disease 2019”, including information regarding researchers at the lab who fell ill in the fall of 2019 like names, symptoms, and job roles.