By Josh Nathan-Kazis
As monkeypox cases continue to rise in the U.S., federal health authorities are scrambling to secure more doses of the vaccine, which the government itself paid to develop. More than 10,000 thousand Americans have fallen ill with the virus.
The latest gambit, announced on Thursday, will see the vaccine's Danish manufacturer send enough bulk vaccine material to a private pharmaceutical contract manufacturer based in Michigan to fill 2.5 million vials.
The agreement is meant to ease a bottleneck at the vaccine maker, Bavarian Nordic (BVNRY), which is meant to deliver 5.5 million vials to the U.S. this year and next. While the company has a large stockpile of bulk vaccine material, the problem is getting that material into vials. According to a note out Thursday from analysts at Cowen, Bavarian Nordic can only fill 250,000 vials a week.
Bavarian Nordic said in a statement Thursday that it would take three months to prepare the U.S. company, a private firm called Grand River Aseptic Manufacturing, to begin filling vials. Bavarian Nordic said Grand River will begin manufacturing doses later this year.
Meanwhile, health authorities on Thursday stood by a plan to switch the administration method of the Bavarian Nordic vaccine, known as Jynneos, despite objections from Bavarian Nordic that were reported earlier this month in the Washington Post. The U.S. plan to stretch its supply of Jynneos doses involves switching from injecting the vaccine through the skin, the traditional administration method for most vaccines, to injecting it into the skin.
The intradermal approach requires a smaller dose, so that each vial could be used to make up five doses, rather than one.
Bavarian Nordic's CEO raised concerns to the Food and Drug Administration about the new approach, which the FDA authorized on an emergency basis on Aug. 9, saying he had concerns about the "very limited safety data available" on the intradermal strategy, according to the Washington Post report.
On a call with reporters on Thursday, the FDA's top vaccines official, Dr. Peter Marks, said that the FDA had adopted the intradermal approach after seeing local health authorities offering only one dose of Jynneos, rather than the required two doses.
"Some of this was in response to seeing additional use of a one-dose delayed strategy, which was ...very concerning because of the absence of data and the emergence of some data to suggest that that might be a strategy that is not as effective as we would like it to be," Marks said.
The FDA has cited a 2015 study that showed that the smaller dose administered into the skin induced the same immune response as the larger dose administered through the skin. The intradermal shots, however, caused more redness, itchiness, and swelling at the injection site.
On the press call, the White House monkeypox coordinator, Robert Fenton, said that the Centers for Disease Control and Prevention has been offering training on administering the vaccine intradermally. He also said that the federal government will make 360,000 vials of the vaccine, which could be used to make 1.8 million doses under the intradermal administration approach, available for states to order as of Monday.
Bavarian Nordic's American Depository receipt rose 8.1% on Thursday, but fell 6.6% in early trading on Friday. The ADR is up 28.4% this year.
Also on Thursday, Bavarian Nordic also said that the plant it uses to manufacture bulk vaccine material, which had been shut down when the monkeypox outbreak hit, is now operational again. That means the company can now resume production of bulk vaccine.
While outbreaks in some nations appear to have stabilized, the trajectory in the U.S. is less clear. Spain, which has reported the second-largest number of cases after the U.S. on a nationwide basis, hasn't seen its rate of new cases a day increase sharply since early July. The figure continues to hover around 100 new cases a day. In the U.K., the average number of new cases a day dropped from the high 30s in early August to the low 20s in recent days.
The U.S. had reported 14,115 cases as of Thursday afternoon, according to the CDC. The country is averaging just over 470 new cases a day, according to an analysis by Our World in Data. That is down from nearly 540 just over a week ago, but sharply up from early August, when the country was averaging fewer than 300 new cases a day.
Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com
$(END)$ Dow Jones Newswires
August 19, 2022 10:27 ET (14:27 GMT)
Copyright (c) 2022 Dow Jones & Company, Inc.
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