The European Medicines Agency (EMA) refused a rolling review of SK Bioscience’s Covid-19 vaccine, SKYCovine, due to “changing pandemic conditions,” a senior official at SK Bioscience said.
A rolling review speeds up the evaluation of a drug or a vaccine during a public health crisis.
The SK Bioscience official said the company plans to submit the vaccine’s data to the WHO to earn Emergency Use Listing (EUL) this week and vowed to win approval from regulatory agencies worldwide as soon as possible.
Hwang Sook-mi, head of Global Regulatory Affairs at SK Bioscience, made a presentation on the development of the Covid-19 vaccine and the company’s regulatory strategy at the 2022 Global Bio Conference at the Grand InterContinental Seoul Parnas hotel on Tuesday.
According to Hwang, SK Bioscience has communicated with the WHO, the EMA, the U.K.’s MHRA, and Korea’s Ministry of Food and Drug Safety to receive approval for SKYCovione (pipeline name: GBP510).
Initially, SK Bioscience had expected that the EMA would grant a rolling review but it did not happen, she said.
The EMA had said a rolling review was possible in December last year but the regulatory agency changed the stance in a pre-submission meeting in May saying a rolling review was impossible because of changes in the regulatory environment, she added.
SK Bioscience submitted conditional marketing authorization (CMA) to the EMA on July 29.
Under the standard timeline for EMA approval, the EMA review takes about 210 days.
“We communicate with regulatory agencies frequently, but there could be changes. So, it is necessary to consider unexpected situations in vaccine development,” Hwang said.
In contrast, approval from the U.K.’s MHRA may not take too long, SK Bioscience said.
SKYCovione is in an expedited review of the MHRA. SK Bioscience has been submitting data to the MHRA since March. The accelerated review could reduce the assessment period from 150 business days to 100 days.
SK Bioscience’s anticipation for MHRA approval is high because the U.K. regulator in April granted conditional approval to Valneva’s Covid-19 vaccine, which went through a study that compared with an existing vaccine.
Since last month, SK Bioscience has been preparing for obtaining the WHO’s EUL.
“We had a pre-application meeting on Aug. 1 to discuss the vaccine’s quality, non-clinical and clinical data. We received confirmation that we could apply for EUL,” Hwang said. “We will submit data this week.”
Normally, it takes about 11 months from the EUL application to marketing approval. Existing Covid-19 vaccines won the nod in four months but recent changes in the pandemic situation may prolong the review time.
If SK Bioscience’s vaccine scores the nod from the MHRA or the EMA, it could accelerate the procedure for the WHO’s EUL review, she added.
SK Bioscience is also working on a universal vaccine but it is still in an early stage of development. It is unclear whether the company could begin a trial within this year.