The SKYCovion COVID-19 vaccine, developed in South Korea with $3.6 million in funding from the Bill and Melinda Gates Foundation, recently received regulatory approval from the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA).
“SK bioscience, a global innovative vaccine and biotech company committed to promoting human health from prevention to cure, has announced today the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted Marketing Authorization (MA) for SK bioscience’s COVID-19 vaccine SKYCovion
(brand name in Korea: SKYCovione) as a primary series for strong immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older,” according to the news release.
Once a vaccine receives Marketing Authorization, it can be marketed and distributed to the public.
It becomes the 8th COVID-19 vaccine authorized by the UK’s independent medicines regulator.
SKYCovion is a nanoparticle vaccine, utilizing a piece of the SARS-CoV-2 virus spike protein along with GlaxoSmithKline’s AS03 adjuvant technology – “an additional ingredient designed to trigger a stronger immune response.”
The vaccine allegedly met the required safety, quality, and effectiveness standards set by the MHRA. This approval has triggered concerns from several scientists, notably British professor Norman Fenton, according to SLAY News.
The MHRA has pointed out that the duration of protection offered by the SKYCovion vaccine remains unknown, and no protection is expected after the initial dose. Furthermore, there is currently no data regarding its safety and efficacy for immunocompromised individuals.
There is also no research regarding its effects on pregnant women or whether the vaccine is excreted in breast milk. The patient information leaflet indicates that the vaccine should not be administered to women who are pregnant or breastfeeding.
To date, SKYCovion has not undergone any carcinogenicity or genotoxicity studies, nor has it been tested for interchangeability with vaccines from other manufacturers. While the vaccine has been licensed for conditional authorization for those over 18, Professor Fenton is pushing for transparency, submitting a Freedom of Information request to MHRA Chief Executive June Raine.
Despite these uncertainties, the vaccine is reportedly being offered to individuals who have previously received multiple COVID-19 vaccines, according to Professor Fenton. This is alarming as the patient information leaflet specifies that two doses of the SKYCovion vaccine are required, with a 28-day gap between doses. Efficacy is not expected until at least 14 days after the second dose.
SLAY News reported citing MHRA guidance:
Duration of protection
The duration of protection afforded by the vaccine is unknown as it is still being determined by ongoing clinical trials.
Immunocompromised individuals
The efficacy, safety and immunogenicity of the vaccine have not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy.
Limitations of vaccine effectiveness
Based on immunogenicity data in SARS-CoV-2 naïve subjects, no protection is anticipated after the first vaccine dose and individuals may not be fully protected until 14 days after their second dose. As with all other vaccines, SKYCovion may not protect all vaccine recipients. Efficacy was not evaluated as part of the clinical trial programme.
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
Concomitant administration with other vaccines has not been studied.
Pregnancy
There is no experience with the use of SKYCovion in pregnant women from clinical trials.
Breastfeeding
It is unknown whether SKYCovion is excreted in human milk.
Fenton expressed concern over the vaccine’s approval, citing a lack of safety data and the need for further studies.
Nevertheless, the European Commission is considering the possibility of a broader rollout for public use across EU nations, despite the concerns raised.
SLAY News reported that an investigation in July 2021 found that the Bill & Melinda Gates Foundation is the primary funder of the MHRA, raising further questions about potential conflicts of interest.
Below is the MHRA guidance document on the untested vaccine:
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