Johnson & Johnson’s COVID-19 vaccine – one of the four approved vaccines in the U.S. – is no longer available in the country, according to authorities.
After the last remaining doses in the country’s stockpile expired May 7, the U.S. Centers for Disease Control & Prevention is directing providers to dispose of leftover shots in accordance with local, state and federal regulations.
A spokesperson for the New Brunswick-based health conglomerate told NJBIZ that Johnson & Johnson is “working closely with U.S. regulators to determine the best path forward.”
“Our focus remains on ensuring our vaccine is available to people most in need globally,” the media representative added.
After Johnson and Johnson’s shot became the third COVID vaccine granted emergency use authorization from the U.S. Food and Drug Administration in February 2021, the drugmaker delivered more than 31.5 million doses to states and other jurisdictions, according to CDC data.
However, only about 19 million people in the U.S. received the J&J vaccine since it became available, leaving about 12.5 million doses unused.
mRNA vaccines from Pfizer-BioNTech and Moderna, which received their EUAs from the FDA in December 2020, represent the majority of shots administered in the U.S. – despite the fact that they require two doses and J&J’s jab is a single dose.
The CDC’s May 15 notice comes four days after the U.S. Department of Health and Human Services officially ended the COVID-19 public health emergency and the administration winds down its pandemic response.
The agency also encouraged those who received J&J’s COVID-19 vaccine to get boosted with the bivalent mRNA dose from Pfizer-BioNTech or Moderna to remain protected.
Initially hailed as a convenient and inexpensive alternative to the other vaccines, J&J’s shot has faced issued with regulators and production over the last two years.
A month into the vaccine rollout, the federal government halted its use due to the risk of thrombosis with thrombocytopenia syndrome (TTS), a syndrome of rare and potentially life-threatening blood clots. About a week later, regulators lifted the pause, saying the benefit of the shot outweighed the risk and attaching a warning label.
However, by May 2022, authorities wound up officially restricting the use of J&J’s shot to adults who could not access other approved vaccines.
At the time, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said, “Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals.”
It also “demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our decisions,” he said. “We’ve been closely monitoring the Janssen COVID-19 Vaccine and occurrence of TTS following its administration and have used updated information from our safety surveillance systems to revise the EUA. The agency will continue to monitor the safety of the Janssen COVID-19 Vaccine and all other vaccines, and as has been the case throughout the pandemic, will thoroughly evaluate new safety information.”
In addition to struggling to regain public confidence in the vaccine, J&J faced manufacturing issues that impacted the shot’s availability. And, by early 2023, the company began scaling back production due to low demand.
In January, The Wall Street Journal reported that J&J liquidated vaccine production contracts with Sanofi and Catalent and was entering arbitration with Rahway-based Merck & Co. after a deal to make the shots didn’t pan out.
Though many developing countries have continued to rely on the vaccine since it’s easier to distribute among hard-to-reach populations, J&J’s jab fell out of favor in the U.S. and other wealthy countries, causing it to fall short of sales expectations.
The drugmaker originally projected between $3 billion and $3.5 billion in 2022 sales but dropped its forecast last spring after a weak Q1 performance. Ultimately, the shot pulled in $2.18 billion in worldwide sales last year.