2022. 02. 09
- A vaccine platform with long-term well-understood safety and efficacy is expected to induce more participants to vaccination who are reluctant to.
- SK started supplying 2 million doses of Nuvaxovid from L-House.
- A total of 40 million doses will be distributed for domestic use in Korea.
A protein-based COVID-19 vaccine with demonstrated safety
and efficacy will be supplied for the first time in South Korea. Experts expect
that the protein-based vaccine known as NuvaxovidTM, COVID-19
Vaccine (recombinant, adjuvanted), will contribute to national immunization by
inducing a higher vaccination rate.
SK bioscience (CEO Jae-Yong Ahn) announced that the
first recombinant protein-based COVID-19 vaccine authorized in South Korea and developed
by Novavax, Inc., Nuvaxovid, began to be
shipped from SK’s vaccine manufacturing plant, L -House in Andong on the
morning of the 9th. The initial volumes to be distributed for domestic use are
about 2 million doses.
Nuvaxovid is developed by Novavax, a biotechnology
company headquartered in the United States that is dedicated to developing and
commercializing next-generation vaccines for serious infectious diseases.
Novavax and SK bioscience have entered into license and contract manufacturing
agreements under which SK bioscience has rights to produce the vaccine for
South Korea, Thailand and Vietnam. SK bioscience is the only company in South
Korea that can conduct the entire manufacturing process from drug substance to drug
product of COVID-19 vaccines. Last year, SK bioscience signed an advance
purchase agreement (APA) with the Korean government for 40 million doses of Nuvaxovid
and will supply the vaccine sequentially based on the plan of the Korea Centers
for Disease Control and Prevention (KDCA).
As the first
protein-based COVID-19 vaccine approved in South Korea, Nuvaxovid is expected
to create a market differentiated from currently commercialized COVID-19 vaccines.
protein vaccine technology has been used for development of current vaccines
including influenza (flu), hepatitis B, and HPV. Nuvaxovid is stored in normal
refrigeration conditions from 2 to 8 degrees Celsius, so it can be distributed
through the current vaccine supply network without thawing at inoculation
Nuvaxovid has demonstrated an overall efficacy of
approximately 90 percent and a reassuring safety profile in results from two
large global pivotal clinical trials. In addition, laboratory studies have
demonstrated a cross-reactive immune response against several variants,
including Omicron, in sera from participants in clinical trials of Nuvaxovid. A recent study conducted by Novavax has demonstrated
a cross-reactive immune response of Nuvaxovid to Omicron and other variants.
Antibody titers against the Omicron variant were 9.3 times higher against the Omicron
variant with a booster dose after 6 months from two initial shots of the same
Also, unlike the currently commercialized COVID-19
vaccines, Nuvaxovid for domestic use in Korea is made of a pre-filled syringe form
for single injection. It can be easily inoculated without dilution at medical
institutions. Experts believe that Nuvaxovid will be able to reduce the burden
on medical staff who are exhausted from the ongoing pandemic situation.
Novavax announced at the JP Morgan Healthcare
Conference in January that the company expects to submit additional filings for
authorization to expand the vaccination age to adolescents 12 years old and
older based on the ongoing research data of the Phase 3 PREVENT-19 clinical trials
in this age group. Novavax also expects to conduct a clinical trial for
children under 12 years old.
Novavax showed the data that antibody titers with a
booster dose of Nuvaxovid after 6 months from two initial shots of the same
vaccine, were increased by 4.6 times. A booster study is ongoing to evaluate
the safety and effectiveness of a third does of the vaccine.
SK bioscience has proven its superb manufacturing
technology by exclusively producing and supplying two of the five vaccines that
have been approved in advanced countries such as the U.S. and Europe. SK bioscience
has previously contributed to the early stage of the pandemic prevention by manufacturing
and supplying drug substance and drug product of AstraZeneca’s COVID-19 vaccine
to global and domestic markets.
Jae-Yong Ahn, CEO of SK bioscience said “In order
to contribute to the national immunization policy under the ongoing pandemic
situation, we have manufactured and distributed various global COVID-19 vaccines.
We are also at a last stage of development of our own COVID-19 vaccine. We will try our best to contribute to keep more
people safe from the threatening with a proven vaccine platform technology.”