Decades after first attempt, RSV vaccine race may soon be over

Near­ly 60 years after the first res­pi­ra­to­ry syn­cy­tial virus (RSV) vac­cine was devel­oped, the Food and Drug Admin­is­tra­tion (FDA) is poised to approve sev­er­al vac­cines next winter.

An RSV vac­cine has nev­er been approved in the Unit­ed States, but the FDA is con­sid­er­ing fil­ing appli­ca­tions for vac­cines from two com­pa­nies, Pfiz­er and Glax­o­SmithK­line, for peo­ple over 60.

Mon­o­clon­al anti­body injec­tions to pro­tect infants from the virus will soon fol­low. It’s not tech­ni­cal­ly a vac­cine, but it serves a sim­i­lar pur­pose. The injec­tions by Sanofi and AstraZeneca have already been approved in Europe, and the FDA began review­ing the com­pa­nies’ appli­ca­tions in January.

RSV infects most peo­ple by the age of two, and it is com­mon to be infect­ed sev­er­al times dur­ing a life­time. Each year, the virus kills more than 10,000 adults over the age of 65 and about 300 chil­dren under the age of 5 in the Unit­ed States.

The surge in RSV cas­es in the Unit­ed States ear­li­er this win­ter, over­whelm­ing chil­dren’s hos­pi­tals, was a reminder of the threat of this virus. Since then, the phar­ma­ceu­ti­cal com­pa­ny race to bring vac­cines to mar­ket has received spe­cial attention.

Ofer Levy, Ph.D., direc­tor of the Pre­ci­sion Vac­cines Pro­gram at Chil­dren’s Hos­pi­tal of Boston, said, “The need for these vac­cines for pub­lic health is very clear, and we’re look­ing for­ward to see­ing which vac­cines demon­strate safe­ty and effi­ca­cy.” We have to make sure we do,” he said.

Data from two vac­cine tri­als were pub­lished Wednes­day in the New Eng­land Jour­nal of Med­i­cine. The first showed that Glax­o­SmithK­line’s FDA-approved vac­cine reduced the risk of symp­to­matic dis­ease by 83% and the risk of severe dis­ease by 94% in old­er adults.

The oth­er is the results of a phase II tri­al of a vac­cine man­u­fac­tured by Janssen, the phar­ma­ceu­ti­cal arm of J&J, which said the vac­cine reduced the risk of severe ill­ness in peo­ple over the age of 65 by 80%.

A total of 11 RSV vac­cines are in active clin­i­cal tri­als in the Unit­ed States, accord­ing to data pro­vid­ed to NBC News by the non­prof­it glob­al health orga­ni­za­tion PATH. Sev­en of them are for the elder­ly and four are for the pro­tec­tion of infants and children.

“This is the begin­ning of a new era,” said Dr. Bernie Gra­ham, senior his advi­sor at Glob­al Health Equi­ty, Mohouse University.

“I think all vac­cines will work well enough to be approved, depend­ing on their side effect pro­file,” added Dr. Graham.

Gra­ham, who pre­vi­ous­ly served as deputy direc­tor of the Cen­ter for Vac­cine Research at the Nation­al Insti­tutes of Health, has made progress since tri­als of an RSV vac­cine in the 1960s were asso­ci­at­ed with two infant deaths. It pub­lished an edi­to­r­i­al Wednes­day along with two new stud­ies explain­ing that.

This fail­ure held back devel­op­ment for decades. But now it turns out that an RSV vac­cine must tar­get spe­cif­ic pro­teins on the sur­face of the virus before it can change its shape, says Graham.

“This is a vac­cine made with atom­ic pre­ci­sion,” he says.

Anoth­er notable vac­cine can­di­date in devel­op­ment is Mod­e­na’s geri­atric injectable, which the com­pa­ny said could be sub­mit­ted to the FDA in July. Anoth­er can­di­date, from Bay­ern Nordic, tar­gets the same demo­graph­ic and is expect­ed to have Phase 3 data by the mid­dle of this year.

Pfiz­er is also con­duct­ing a sec­ond vac­ci­na­tion tri­al in preg­nant women to pro­tect chil­dren from RSV. In old­er adults, the Pfiz­er vac­cine was shown to reduce the risk of severe ill­ness by 86%. When admin­is­tered to preg­nant women, it was found to be 82% effec­tive against severe dis­ease in infants dur­ing the first 90 days of life, and 69% effec­tive dur­ing the first six months.

Levy says hav­ing mul­ti­ple options will be important.

“Don’t put all your eggs in one bas­ket,” he said. “The first is not to rely on one man­u­fac­tur­ing chain. Sec­ond, in my opin­ion, hav­ing mul­ti­ple plat­forms is an advantage.

A vac­cine plat­form is a tech­nol­o­gy for stim­u­lat­ing an immune response. Mul­ti­ple plat­forms in the mar­ket are ide­al, as age, gen­der and immune sta­tus respond dif­fer­ent­ly to vaccines.

Gra­ham said he hopes that even­tu­al­ly an RSV vac­cine for infants will also be approved.

“If we can find some­thing that works and is safe for chil­dren aged 6 months to 5 years, we’ll com­plete what we can do for RSV,” he said.