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A nurse is preparing to inject a medical worker with the Pfizer-BioNTech vaccine in Rome on Monday.
Filippo Monteforte / AFP through Getty Images
There are not enough Covid-19 vaccines approved from
Pfizer,
BioNTech and Moderna, so it was good news that
Novavax
and
Arcturus Therapeutics Holdings
they were moving on to the next stages of vaccine testing.
But when Novavax (scorer: NVAX) said Monday that the US phase 3 process was starting, the stock dropped 10% that day to close at $ 116.85. It rose 1% in early trading on Tuesday. The reaction to Arcturus’ news was even more discouraging.
Following Monday’s closure, Arcturus (ARCT) said it would conduct a phase 2 study with its vaccine in Singapore. He published data from the initial clinical study of the photographs, which use messenger RNA technology along the lines of the Pfizer (PFE), BioNTech (BNTX) and Moderna (MRNA) vaccines.
However, as analysts studied the Arcturus data, they found it unimpressive. With a wave of downgrades on Tuesday morning, the Arcturus stock fell 52% since Monday’s close to $ 43.93.
Novavax began a phase 3 study in the UK earlier this year and this 15,000-person track is now fully registered. The company’s scientists are waiting to see the difference in the number of Covid cases between those receiving placebo vaccines and those receiving the Novavax vaccine,
Early photo tests generated impressive levels of virus-neutralizing antibodies in the recipients. The vaccine contains SARS-CoV-2 virus-like protein particles, which Novavax produces through a standard genetic engineering process.
Starting this week, Novavax aims to enroll 30,000 volunteers in the US and Mexico for its Phase 3 study. Public health experts feared that recruitment for such placebo-controlled Covid vaccine routes would become more difficult, following US authorizations for Pfizer / BioNTech and Moderna vaccines. Starting now with the pivot test, Novavax is behind the early beginnings of developers
Johnson & Johnson
(JNJ), even if Pfizer and Moderna increase production.
As an incentive, Novavax probably intends to administer the active vaccine to two-thirds of its volunteers and placebo to one-third. Previous developers have divided their tasks in half and half.
Disappointment from Arcturus’ phase 1 month data focuses on the levels of antibodies generated by his photos. The company has raised hopes that its vaccine will stand out, providing immunity after just one dose. But after the first of the two photos in the phase 1 study, antibody levels were only comparable to levels seen in patients who recovered from a Covid-19 infection. The second boom hit only a slight improvement, Guggenheim analyst Seamus Fernandez said in a note Tuesday.
The Guggenheim analyst maintained his Buy rating on Arcturus, but said in his note that the data “raised more questions than answers.” Rival vaccines, including Novavax, have generated much higher levels of antibodies after two vaccines. Unless Arcturus can prove that a single dose of the vaccine is superior, Fernandez said, his product may not be a viable competitor.
Other analysts were less forgiving. Arcturus shares received five downgrades after Monday, including four that reduced it to Hold and one that reduced it to Sell.
At Raymond James, analyst Steven Seedhouse said in a note on Tuesday that he was giving up Arcturus from a superior performance to a market performance (the equivalent of a Hold) because single-dose levels of neutralizing antibodies were “overwhelming.”
Data from the Phase 3 study of Pfizer-BioNTech and Moderna vaccines showed that neutralizing antibody levels were correlated with Covid protection of the photos, Seedhouse said. So, with the intermediate data from Arcturus equal only to those from convalescent Covid patients – instead of several times higher, like the other vaccines – investors will not be interested in Arcturus unless they can prove their advantage with a single dose in -a phase 3 study is expected.
Write to Bill Alpert at [email protected]