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The Subject Expert Committee (SEC) for Vaccines, which review proposals and advice Drugs Controller General (India) in matters for biologicals, has recommended approval of protocol amendment request from UK-based GSK for its stalled respiratory syncytial virus (RSV) maternal vaccine trial.
The company has earlier this year decided to stop enrolment and vaccination in trials evaluating its potential RSV maternal vaccine candidate in pregnant women due to safety concerns.
It has presented its proposal for protocol amendment in two of the studies in India, before the committee.
The committee noted that the applicant has suspended further enrollment globally due to urgent safety concerns and as per the Independent Data Monitoring Committee (IDMC) recommendation.
The proposed protocol amendment is mainly for safety follow up. "After detailed deliberation, the committee recommended for approval of proposed protocol amendment," said the SEC in its minutes of the meeting held on June 15, 2022.
GlaxoSmithKline plc (GSK) on February 18, 2022, announced that it has voluntarily paused enrolment and vaccination in a GRACE phase III trial, evaluating its potential RSV maternal vaccine candidate, as well as two other trials investigating this candidate in pregnant women.
The investiGational RSV mAternal vacCinE study (GRACE) study is a double-blind phase 3 study scheduled to be conducted in up to 10,000 pregnant women aged 18-49 years.
The decision was made following a recommendation from the IDMC based on an observation from a routine safety assessment. Monitoring safety signals is an integral part of the clinical development process for potential new vaccines.
However, this decision does not impact the ongoing phase III trial for RSV older adults of 60 years and above and this trial remains on track with an anticipated data readout in the first half of 2022, it said.
On February 28, the company announced that it has decided to stop enrolment and vaccination in trials evaluating the maternal vaccine candidate in pregnant women.
"Further analysis to better understand safety data from these trials is ongoing, and the relevant regulatory authorities have been informed," said the company during the time.
It was in November, 2020, the company announced that it is starting the phase III global study for the maternal vaccine.
While there are no vaccines available for RSV infection on infants, companies including Pfizer and GSK has been on the race to develop a vaccine in the short term. While GSK's maternal vaccine has faced the setback, Pfizer's vaccine is on a promising track according to news reports.
RSV-associated lower respiratory tract illnesses (LRTIs) cause significant global morbidity and mortality in infants under 6 months, including more than 1.4 million hospitalisations every year.
"It is estimated that every year, 33 million cases of RSV occur in children less than 5 years of age globally, with more than 1.4 million hospitalisations of infants under 6 months of age. RSV is a leading cause of respiratory infections such as bronchiolitis (inflammation and congestion of the small airways or bronchioles of the lung) and viral pneumonia (an inflammatory condition of the lung small air sacs or alveoli) in infants," said GSK on 2020.
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