A three-dose vac­cine se­ries was 73.2% ef­fec­tive in pre­vent­ing Covid-19 for chil­dren be­tween 6 months and 4 years old, Pfiz­er and BioN­Tech said Tues­day morn­ing.

The ef­fi­ca­cy up­date comes af­ter Pfiz­er and BioN­Tech’s vac­cine was au­tho­rized for emer­gency use in the youngest age group in June. That au­tho­riza­tion was sup­port­ed by in­ter­im da­ta that sug­gest­ed the vac­cine se­ries was 80% ef­fec­tive, with 10 symp­to­matic Covid cas­es in the vac­cine co­hort.

The fi­nal ef­fi­ca­cy re­sults came af­ter 21 cas­es of symp­to­matic in­fec­tion. The da­ta, how­ev­er, came with a wide con­fi­dence in­ter­val of 43.8% to 87.6% ef­fi­ca­cy.

Pfiz­er and BioN­Tech not­ed that the tri­al was con­duct­ed when Omi­cron BA.2 was dom­i­nant and when BA.4 and BA.5 were still emerg­ing, so the ef­fi­ca­cy re­sults against the lat­ter two strains were in­con­clu­sive.

Mex­i­co to file com­plaint to UN over miss­ing Covid shots

In a press con­fer­ence Mon­day, Mex­i­can Pres­i­dent An­dres Manuel López Obrador said his gov­ern­ment would file a com­plaint to the UN for not de­liv­er­ing Covid-19 vac­cines it paid for up­front.

López Obrador said the UN still owes Mex­i­co $75 mil­lion in vac­cines. Mex­i­co had or­dered vac­cines through a UN and WHO ini­tia­tive known as CO­V­AX, which was cre­at­ed to ac­cel­er­ate eq­ui­table ac­cess to Covid-19 vac­cines.

Ac­cord­ing to a UN CO­V­AX track­er, Mex­i­co is owed over 26 mil­lion dos­es and has re­ceived 24.6 mil­lion.

Russ­ian re­search in­sti­tute an­nounces new ver­sion of Sput­nik V adapt­ed to Delta and Omi­cron

Fol­low­ing the foot­steps of oth­er vac­cine de­vel­op­ers, the Gama­leya Re­search In­sti­tute — a Russ­ian med­ical re­search cen­ter — and the Russ­ian Di­rect In­vest­ment Fund (RDIF) have cre­at­ed a new Sput­nik V vac­cine that is adapt­ed to Delta and Omi­cron.

The orig­i­nal Sput­nik vac­cine was the first to be ap­proved by any coun­try, but Rus­sia’s in­va­sion of Ukraine like­ly quashed any fu­ture for that vac­cine, as the US and EU sanc­tioned RDIF. Ac­cord­ing to a World Trade Or­ga­ni­za­tion track­er, Sput­nik V has made up a mere 2% of the glob­al vac­cine mar­ket as of May.

Mod­er­na and Pfiz­er are both work­ing on bi­va­lent vac­cines that tar­get Omi­cron. Mod­er­na’s bi­va­lent vac­cine nabbed EU au­tho­riza­tion last week, and Pfiz­er said it has sub­mit­ted an EUA for its bi­va­lent vac­cine, with a sub­mis­sion to Eu­ro­pean au­thor­i­ties to fol­low in the com­ing days.

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.