As Pfizer’s first COVID-19 vaccine doses roll across the U.S., analysts size up the hurdles ahead – FiercePharma

Afterahistorically eventfulfewdays for COVID-19 vaccinesfeaturing key meetings at the FDA and CDC, plusan emergency authorizationa massive immunization programkickedoff Monday morning.

Vaccinations with Pfizer and BioNTech's newly-minted shotstartedin the U.S. Mondayless than 11 months after the countrys first COVID-19 case. Whileit's a historic moment, and the speed to market has been unprecedented,SVBLeerinkanalysts point out the hurdlesstill ahead.

Despite high efficacy figuresfor the Pfizer/BioNTech and Modernavaccines in pivotal studies, theres still widespread hesitancy among the general public, the analysts wrote.

Only about50% to 60% of the population plans to get the vaccine, surveys show. Even healthcare workers have their own reservations. Recent stories highlighting cases of anaphylaxis and Bell's palsy after vaccinationhave intensified thoseconcerns, the analysts wrote.

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Supply will also be alimiting factor formonths. Moderna has said it can make 20 million doses available to the U.S. by the end of the year, and up to 100 million doses by the end of the first quarter of 2021; it agreed Friday to addanother 100 million by the end of Q2.

Meanwhile, Pfizer expects to ship 25 million doses in the remainder of 2020 and up to 100 million in the first quarter of next year.

If the companies meet those targets, about 100 million Americans could get vaccines in the first 3 months of 2021, and 50 million in Q2. Both vaccines require two doses.

As Pfizer ships its first doses, Moderna is gearing up for its own FDA advisory committee meeting this week. The company could be shipping doses next week if all goes well, the analysts figure.

And then there are thenow-well-knowncold-chain requirements for the mRNA vaccines. Pfizer has designed special containers to help its doses stay at ultra-cold temperaturesuntil use, and distributorsfrom air to truck to clinical have been training to handle the vaccine properly on its way to people's arms.

RELATED:Weak clinical data force Sanofi, GSK to delay COVID-19 vaccine

While the Pfizer and Moderna programshave succeededin late-stage testing, the analysts also raised concerns that several of the worlds leading vaccine makershave either suffered R&D setbacks orsignaled awillingness to step away from COVID-19 shot research.

Sanofi and GSKon Friday reported aninsufficient response in older adults for their partnered vaccine so that program will be tied up in thetime-consumingprocess of finding a correct dose, the analysts pointed out. Australias CSL, a leading flu vaccine provider, discontinued its program after itcaused false positiveson HIV tests.

Merck & Co.recentlysaid it would have to carefully look at its own prospects in COVID-19, considering the highbar set by Pfizer and Modernas programs, the analysts wrote.

And all of that follows a high-profile setback for AstraZeneca: Researchers mistakenly gave a half-sized firstdose of its adenovirus vaccine to one group of participants in its phase 3 vaccine, muddying the waters on efficacy and delaying the company's application for an approval.

This then means that four of the worlds large vaccine companies ... are now removed from the forefront of COVID vaccine development, the analysts wrote. Although these actions are justifiable from a research or commercial perspective, we are concerned that there may be only limited backup options behind Pfizer and Moderna.

RELATED:AstraZeneca, J&J COVID-19 shots must succeed to meet U.S. vaccination goal: Slaoui

Its not surprising for companies to see setbacksthrough an R&D process, the analystspointed out. Pfizer,BioNTechand Moderna have thus far managed quite an operational feat, they allowed.

Still, even with those companies' successesand withthe setbacks at Sanofi and other companiesOperation Warp Speed head Moncef Slaoui recently said the U.S. will need doses from AstraZeneca and Johnson & Johnson to meet its demand.

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As Pfizer's first COVID-19 vaccine doses roll across the U.S., analysts size up the hurdles ahead - FiercePharma