FILE PHOTO: A woman holds a small bottle labeled with a "Vaccine COVID-19" sticker and a medical syringe in this illustration taken April 10, 2020. REUTERS/Dado Ruvic/Illustration/File Photo
Malaysia has already moved in recent days to secure its first batch of COVID-19 vaccine doses for 20 per cent of its 32 million population, but will need more to achieve its targeted vaccination rate of 70 per cent or 22.4 million people.
In the global race to find effective and safe COVID-19 vaccines, there are now 13 potential options — including the Pfizer-BioNTech vaccine to be supplied to Malaysia — that the Malaysian government can choose from, depending on results from clinical trials.
According to the World Health Organisation (WHO), there are currently 51 vaccine candidates undergoing clinical evaluation or tests, with another 163 in the preclinical evaluation stage, as of December 2.
Out of the 51 vaccine candidates in clinical evaluation, 13 were already at Phase III or the final stage of clinical tests before they can start to be used.
Here are details on the 13 vaccine candidates based on a regularly updated list by the WHO online, as well as news reports and company announcements, and WHO’s explanation of the type of vaccines they fall under:
Such vaccines use a form of the virus that has been weakened or inactivated, which means it does not cause the disease but still generates an immune response from the body.
The vaccine candidate developed by private China-based firm Sinovac Biotech Ltd’s subsidiary Sinovac Life Sciences Co — “CoronaVac” — is being tested with two doses, with the second given 14 days after the initial dose. This vaccine candidate can reportedly be stored at normal fridge temperatures of 2 to 8 degrees Celsius.
After initial clinical trials in China, Phase III trials are being conducted in Brazil as announced by Sinovac in July with the expected participation of nearly 9,000 healthcare professionals, and in Bandung, Indonesia. The company also said in September it will conduct Phase III trials in Turkey, with the first stage involving 1,300 healthcare workers and the second stage involving about 12,000 of the general population, with two doses of either vaccine or placebo to be given to them at a two-week interval.
No, you didn’t read wrong. The two points above are because one company has two vaccine candidates undergoing trials at two different facilities.
The state-owned China National Pharmaceutical Group Co, Ltd (Sinopharm) is conducting Phase III clinical tests for two vaccine candidates developed by Wuhan Institute of Biological Products and Beijing Institute of Biological Products respectively, with testing involving two dosages given 21 days apart.
On November 17, GI Healthcare Resources Sdn Bhd, which is partnering Sinopharm, said the vaccine candidates are undergoing Phase 3 clinical trials involving more than 55,000 individuals in 10 countries including the UAE, Bahrain, Egypt, Morocco.
The Malaysian company also noted that the emergency use of the two vaccine candidates have been approved in China, the UAE and Bahrain for over one million frontliners.
GI Healthcare also proposed to sponsor 10,000 of Sinopharm’s vaccines — which can be stored between 2 to 8 degrees Celsius — for emergency use in Malaysia by frontliners.
India’s vaccine manufacturer Bharat Biotech developed its vaccine candidate — “Covaxin” — in collaboration with the Indian Council of Medical Research (ICMR)-National Institute of Virology (NIV).
On November 16, the company announced the start of Phase III trials in India that will involve 26,000 volunteers above the age of 18, with two doses of either Covaxin or placebo to be injected about 28 days apart.
Such vaccines use a genetically-engineered virus that do not cause disease but produce coronavirus proteins to generate an immune response from the body.
UK-based biopharmaceutical firm AstraZeneca is the manufacturer of “AZD1222” formerly known as “ChAdOx1 nCoV-19”, the vaccine candidate invented by University of Oxford together with the university’s spin-out company Vaccitech.
According to AstraZeneca, the AZD1222 vaccine candidate can be stored, transported and handled at normal refrigerated conditions of 2 to 8 degrees Celsius for at least six months.
On November 23, AstraZeneca said interim analysis of its late-stage clinical trials on adults aged above 18 in the UK (Phase II/III with 12,390 participants) and Brazil (Phase III with 10,300 participants) showed positive results, with two doses of either AZD1222 or placebos injected at least one month apart. The UK trial with half-dose followed by full dose gave a higher effective rate of 90 per cent as compared to the 62 per cent efficacy in the Brazil trial involving two full doses.
Including the UK and Brazil trials, the company plans to enrol 60,000 participants in clinical tests, with trials ongoing in the US, Japan, Russia, South Africa, Kenya and Latin America, and with planned trials in other countries in Europe and Asia.
China’s listed firm CanSino Biologics Inc co-developed the Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) “Ad5-nCoV” — otherwise known as “Convidecia” — together with the Beijing Institute of Biotechnology, Academy of Military Sciences. The company said the vaccine candidate is stable at between 2 to 8 degrees Celsius.
On November 7, CanSino said it has launched Phase III trials in Mexico, with plans to recruit a total of 15,000 participants, the first of whom would be vaccinated on November 6. The company also said it was conducting Phase III clinical development in Russia and Pakistan, and was on November 21 reported to be planning to start late-stage trials in Argentina and Chile.
On September 23, Solution Biologics Sdn Bhd (Solbio), a subsidiary of Solution Group Bhd, signed a registration, manufacturing and commercialisation agreement with CanSino.
Under the five-year agreement, Solbio is expected to apply for a market authorisation certificate from Malaysia’s National Pharmaceutical Regulatory Agency for the local registration of Convidecia after Phase III trials are completed, with Solbio to partner with CanSino for the final manufacturing process of the vaccine candidate in Malaysia before marketing and distributing it here.
Russia’s Gamaleya National Center of Epidemiology and Microbiology said the Sputnik V vaccine candidate it developed involves what it described as a unique method of using two different types of adenovirus vectors (rAd26 and rAd5) for the first and second doses of vaccination with the aim of producing a stronger and longer-term immune response. The doses are said to be given 21 days apart. Gamaleya Center claims Sputnik V to have an efficacy rate of more than 90 per cent.
On November 24, Russia’s sovereign wealth fund Russian Direct Investment Fund (RDIF) said the cost of Sputnik V in international markets will be less than US$20 for two doses, while the freeze-dried form of the vaccine candidate is said to be able to be stored at a temperature of between 2 to 8 degrees Celsius.
According to the Gamaleya Center and RDIF, a Phase III trial in Russia involving 40,000 volunteers is underway, and Phase III trials are also ongoing in other countries such as Belarus, the UAE and Venezuela, while a Phase II-III trial is being undertaken in India.
US-based healthcare firm Johnson & Johnson’s Janssen Pharmaceutical Companies said its vaccine candidate — “JNJ-78436735” which is also known as “Ad26.COV2.S” — is estimated to remain stable for two years at -20 degrees Celsius and at least three months at 2 to 8 degrees Celsius, noting that this means that it would not need new infrastructure to deliver it as it would be compatible with standard vaccine distribution channels.
On September 23, Johnson & Johnson announced the start of Janssen’s Phase III trial involving up to 60,000 volunteers aged 18 and above in three continents covering the countries of Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa and the US, with volunteers to get a single dose of either the vaccine candidate or a placebo.
On November 15, Johnson & Johnson said it has started a parallel Phase III trial which will involve up to 30,000 participants aged 18 and above in Belgium, Colombia, France, Germany, the Philippines, South Africa, Spain, the UK and US, with this trial to test the safety and effectiveness of a two-dose regimen. WHO data indicates the doses are to be given 56 days apart.
According to the WHO, such vaccines use harmless fragments of proteins or protein shells that mimic the COVID-19 virus to safely generate an immune response from the body.
US-based late-stage biotechnology firm Novavax said its vaccine candidate “NVX-CoV2373” can be stored at 2 to 8 degrees Celsius that would enable cold chain management using existing infrastructure.
On November 30, Novavax said it has fully enrolled 15,000 participants in its Phase III trial in the UK with interim data expected as soon as early first quarter 2021, and said it expects to start its Phase III clinical trial in the US and Mexico in the coming weeks. The company had previously said it plans to enrol up to 30,000 participants in the US and Mexico for the trials. WHO data showed that the trials involve two doses given 21 days apart.
China’s listed firm Chongqing Zhifei Biological Products Co., Ltd’s subsidiary Anhui Zhifei Longcom Biopharmaceutical Co, Ltd had co-developed its vaccine candidate together with the Institute of Microbiology of the Chinese Academy of Sciences.
WHO’s data indicate dosages were trialled at three doses given at 28-day intervals.
In mid-November, the Uzbekistan government reportedly said 5,000 volunteers aged between 18 and 59 will participate in Phase III trials for the candidate vaccine for a year.
Such vaccines use genetically engineered RNA or DNA to generate a protein that safely prompts an immune response from the body.
US-based biotechnology firm Moderna and investigators from the US National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID)’s Vaccine Research Center had co-developed the mRNA-based vaccine candidate “mRNA-1273”.
Moderna on July 27 announced that it had started its Phase III trials in the US and said on October 22 that it had completed enrollment of 30,000 participants for this trial including more than 25,650 who had already received second doses of the vaccine candidate. The company later said in November that initial interim analysis indicated efficacy of more than 90 per cent. WHO data indicated the two doses are given 28 days apart.
On November 16, Moderna said the mRNA-1273 vaccine candidate can be shipped and kept for longer-term storage for up to six months at -20 degrees Celsius which is equivalent to most home or medical freezer temperatures, adding that this standard freezer temperature can be met by most of the pharmaceutical distribution firms.
Moderna also said on the same day that it expects the vaccine to remain stable at standard refrigerated conditions of 2 to 8 degrees Celsius for up to 30 days within the six-month shelf life and noted that this would enable storage at most pharmacies, hospitals or doctors’ offices; further noting that it can be kept at room temperature conditions for up to 12 hours once removed from the refrigerator for administration of the vaccine.
US-based listed firm Pfizer and listed German firm BioNTech SE’s co-developed mRNA-based vaccine candidate “BNT162b2” had entered Phase III trials on July 27 and by November had close to 44,000 participants enrolled in the trials carried out in the US, Germany, Turkey, South Africa, Brazil and Argentina. The companies said the vaccine candidate has an efficacy rate of more than 90 per cent, based on data from the Phase III trials. WHO data indicate that two doses are given 28 days apart.
On December 2, Pfizer said it has expertise in cold-chain shipping and the established infrastructure required for the vaccine’s distribution, including distribution hubs that can keep the vaccines for up to six months.
On the same day, both companies said they had developed specially-designed temperature-controlled shippers that can maintain the -70 degrees Celsius temperature recommended to store the vaccines with just dry ice, and that these shippers can keep this temperature for 10 days if unopened which would enable global transportation. A GPS-enabled thermal sensor in each shipper will enable continuous and round-the-clock location tracking and the monitoring of temperature of each vaccine shipment.
The shippers can be used as a temporary storage solution once opened at vaccination centres to keep the -70 degrees Celsius temperature for up to 30 days with re-icing every five days, while the thawed vaccine vial can be kept for up to five days at refrigerated conditions of 2 to 8 degrees Celsius.
Also on December 2, the UK became the first country to allow the Pfizer-BioNTech’s vaccine candidate to be used on citizens not involved in clinical trials, via temporary authorisation for its emergency use.
Separately, BioNTech and listed Chinese firm Shanghai Fosun Pharmaceutical (Group) Co., Ltd in mid-November announced that they would begin Phase II trial in China. Both companies had previously agreed on a partnership to develop and commercialise “BNT162b2” in China, Hong Kong, Macau and Taiwan.
Canada-based biopharmaceutical firm Medicago Inc’s plant-derived and RNA-based vaccine candidate features recombinant Coronavirus Virus-Like Particles (CoVLP) that mimic the COVID-19 virus structure that allows it to be recognised by the immune system.
Medicago has entered into two separate collaboration partnerships with the UK-based GSK and the US-based Dynavax Technologies Corporation to combine Medicago’s CoVLP with their respective adjuvants. Medicago said the use of adjuvants can boost the immune response and reduce the amount of antigen required for each dose, which would in turn enable the production of more vaccine doses.
Medicago began its Phase I clinical trial on July 13 with its vaccine candidate alone as well as doses that feature either GSK or Dynavax’s adjuvants, and on November 12 announced that it will be launching Phase II/Phase III clinical trials with the vaccine candidate featuring GSK’s adjuvant to confirm the safety and effectiveness of a dosing regimen of two doses given 21 days apart.
According to Medicago, the Phase III part of the trial should start before the end of 2020 and will involve over 30,000 participants in North America, Latin America and/or Europe.
On November 27, Prime Minister Tan Sri Muhyiddin Yassin announced that Malaysia had on November 24 signed a preliminary deal with Pfizer to buy 12.8 million doses of COVID-19 vaccine — sufficient for 6.4 million persons or 20 per cent of Malaysia’s population. The 12.8 million doses are expected to be delivered quarterly next year in installments of one million doses (first quarter 2021), 1.7 million (second quarter), 5.8 million (third quarter), 4.3 million (fourth quarter).
While the government plans to provide COVID-19 vaccination for free to Malaysians with a priority on frontliners, senior citizens and high-risk groups but would charge foreigners a fee for such vaccination, Malaysia will only start using such vaccines if approved by the country’s National Pharmaceutical Regulatory Agency (NPRA).
Muhyiddin also said that the Health Ministry would begin this December Phase III trials involving 3,000 participants for the COVID-19 vaccine developed by China’s Chinese Academy of Medical Science’s Institute of Medical Biology through a government-to-government initiative, with local authorities to review the vaccine’s safety profile and the research protocol before the clinical study starts here. Based on WHO’s list of vaccine candidates, this is likely a vaccine candidate of the inactivated virus type with two doses given 28 days apart and already at the Phase I/Phase II trial stage.
Muhyiddin added that the Malaysian government is actively negotiating with 10 of the 12 developers of COVID-19 vaccine candidates that are already in Phase III trials, with plans to buy the vaccines from multiple sources to ensure supply for at least 60 per cent of the Malaysian population or 18 to 19 million persons.
Minister Khairy Jamaluddin said on November 27 that the government is working to secure COVID-19 vaccine doses for an initial target of 70 per cent of Malaysia’s population to achieve herd immunity, with 20 per cent already secured through the Pfizer deal and 10 per cent also secured through a US$22,656,200 (about RM92.3 million) payment by Malaysia for the Covax facility — an international initiative by Gavi, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations, and the World Health Organisation.
On November 30, Khairy declined to disclose the Pfizer vaccine’s price due to a non-disclosure agreement but said it would be less than RM100 per dose. He also explained that Pfizer will handle and deliver shipments directly in relation to the ultra-cold supply chain needed, and assured that Malaysia’s universities and research institutes have ultra-low temperature freezers that can be redeployed if needed to store the vaccines while also noting that the country’s storage plans would take into account the staggered delivery schedule of the 12.8 million doses.
On December 2, Health director-general Tan Sri Dr Noor Hisham Abdullah said the Health Ministry will monitor the use of Pfizer-BioNTech’s vaccine in the UK including its effectiveness and any possible side-effects, and that Malaysia will wait for the results of the Phase III studies before deciding and also stressed that all vaccines must be reviewed by the NPRA with no exceptions for emergency use. — Malay Mail
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