- Johnson & Johnson expects sales of its coronavirus vaccine to quickly mount over the rest of the year after safety concerns and significant delays in manufacturing weighed heavily on uptake of the one-dose shot in the U.S.
- The pharmaceutical company on Wednesday predicted vaccine sales will total $2.5 billion this year, despite recording only $264 million in sales over the first six months of the year. While large, J&J's forecast is far below the $26 billion and $19 billion that Pfizer and Moderna, respectively, expect to earn from their vaccines in 2021.
- J&J's vaccine is also at the center of debate over whether additional doses are needed to guard against waning protection from COVID-19 and the threat of more transmissible variants like Delta. Laboratory studies of J&J's shot have returned conflicting results and, on Wednesday, company executives deferred to public health officials on guidance around boosters.
J&J's vaccine has been cleared for use in dozens of countries worldwide, backed by data from a large Phase 3 study that showed modestly strong protection against COVID-19 with only one dose.
But since the vaccine became available, it's been dogged by safety concerns, first over a rare blood clotting syndrome that was also linked to AstraZeneca's similar shot and then more recently over an association with an uncommon neurological disorder called Guillain-Barré.
Both side effects affected only a handful of people out of tens of millions vaccinated and, in each case, regulators judged after careful consideration that the benefits still outweighed any risk. But the concerns did appear to dampen use in the U.S. and overseas, leading to temporary suspensions in vaccinations in a number of countries.
Major manufacturing problems at a Maryland factory run by Emergent Biosolutions, meanwhile, led to tens of millions of J&J vaccine doses being thrown out, some of which had been earmarked by the U.S. for distribution abroad.
To date, about 13 million people in the U.S. have been vaccinated with J&J's shot, compared to nearly 86 million with Pfizer's and almost 63 million with Moderna's.
The challenges appear to have translated into lower sales for J&J, which priced its shot much lower than either Pfizer or Moderna. Over the first half of the year, J&J recorded $264 million in sales, calculating a per-dose price of around $5. That latter figure could rise to as much as $8 over rest of 2021, J&J executives said Wednesday, although the company doesn't expect to earn a profit.
Overall, J&J predicts sales of between $92.5 billion and $93.3 billion in 2021 when including its coronavirus vaccine.
J&J didn't forecast, however, expected sales for 2022 or beyond, citing uncertainty over the need for booster doses and the threat posed by coronavirus variants.
"In terms of the booster, whether it's needed or not, I think we should really defer to health officials around the world as to what that call will be," said Joe Wolk, J&J's chief financial officer, on a conference call Wednesday discussing the company's second quarter earnings. "We do like the durability of at least eight months for our vaccine."
The durability estimate Wolk cited comes from data on nearly two dozen participants in an early study of the vaccine. Researchers found immune responses triggered by one dose of J&J's shot lasted at least eight months. Another analysis of blood samples from eight volunteers in the company's Phase 3 study indicated vaccination spurred neutralizing antibodies to the Delta variant.
But a new study from researchers at New York University, posted online on the pre-print server biorxiv, showed antibodies against Delta declined to lower levels in people who received J&J's vaccine versus those given Pfizer's or Moderna's, suggesting a booster dose may be needed.
Public health officials in the U.S. have pushed back on calls for recommended boosters now, citing the need for more data. Pfizer, however, is moving ahead with plans to formally ask the Food and Drug Administration for authorization of a third dose.
On Thursday, an expert panel of advisers to the Centers for Disease Control and Prevention will discuss booster shots for people who are immunocompromised.