FDA begins a probe following the disclosure of Johnson & Johnson (NYSE:JNJ) on Wednesday that one of the active ingredients in a batch of COVID-19 vaccines at its contractor’s premises does not meet quality criteria.
Scraps a batch of COVID-19 vaccine
According to a communiqué from Johnson & Johnson (NYSE:JNJ), it scraps the COVID-19 vaccine after identifying an active ingredient that failed to meet the quality standard at a facility owned by Emergent Biosolutions Inc. As a result; the company halted the distribution of doses from this batch.
The US FDA will send a team of specialists to ascertain the facts at the contract manufacturing site of Johnson & Johnson.
The MD of Emergent, Gaithersburg, said it has isolated ingredients that failed to meet the specified quality standard. The company will dispose of the entire batch of ingredients.
According to a communiqué from the Whitehouse on Thursday, the incident will not affect the promised supply of vaccines by Johnson & Johnson in the US. The company will deliver 100 million doses during the mid-year in the US, fulfilling the $1 billion purchase accord signed with the government.
Jen Psaki, a press secretary at the Whitehouse, said Johnson & Johnson assured the government that it will to respect the timeline. She further said the issue is detected after ensuring stringent quality practices at the supplier premises.
Drug plants need FDA nod
Answering the query of why the Whitehouse did not reveal the details to the public last week, Jen said the Baltimore plant is yet to receive the US FDA’s approval. The contract manufacturing plants can produce ingredients for the vaccines. However, the drug manufacturers need the approval of the FDA before releasing them into the market.
Johnson & Johnson is the third manufacturer in the US to receive approval for COVID-19 vaccines. The health authorities in the US are counting on boosting the supply of single-shot vaccines after the arrival of Johnson & Johnson’s supplies. Other notable suppliers of COVID-19 vaccines include Moderna Inc and Pfizer Inc.
Emergent is working to satisfy the US FDA’s quality requirements in the production of coronavirus vaccines.