About 15 million doses of the single-shot coronavirus vaccine made by Johnson & Johnson were ruined in a factory error in the United States, The New York Times reported -- a blow to the company's efforts to quickly boost production.
When contacted by AFP, the pharmaceutical giant said it had identified a batch of doses at a plant in Baltimore run by Emergent BioSolutions "that did not meet quality standards" but did not confirm the specific number affected.
The company also said the batch "was never advanced to the filling and finishing stages of our manufacturing process."
"Quality and safety continue to be our top priority," it said.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
The Times report however signaled that issues with quality control could affect future output, with the Food and Drug Administration expected to investigate.
The FDA told AFP it was "aware of the situation" but declined to comment further.
Johnson & Johnson said it was sending more experts to the site to "supervise, direct and support all manufacturing of the Johnson & Johnson COVID-19 vaccine," which would allow it to deliver an additional 24 million shots "through April."
The Emergent BioSolutions plant had not yet been authorized by US regulators to manufacture a "drug substance" for the J&J vaccine, the company said, but US media reported that it was expected to produce tens of millions of doses in the near future.
The J&J vaccine has won praise for its single dosage and because it does not need to be frozen -- unlike the shots from Moderna and Pfizer -- making distribution much simpler.
"We continue to expect to deliver our COVID-19 vaccine at a rate of more than one billion doses by the end of 2021," J&J said.Follow our full coverage of the coronavirus pandemic here.