Parallel COVID-19 vaccines will be available in Ma
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Posted On: 01/25/2021 5:29:17 AM
Parallel COVID-19 vaccines will be available in Malaysia to counter halal uncertainty
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BY RICHARD WHITEHEAD
25 JAN 2021
NEWS
SALAAM GATEWAY
KUALA LUMPUR - While little is known yet about the halal status of all the official coronavirus vaccines Malaysia will distribute this year, other vaccines that will be certified halal are still expected to be available.
These parallel vaccines will be ordered by physicians at the request of their patients. The public may ask for these drugs for various reasons, including beating the queue for vaccination and doubts over the safety—or halal-ness—of government-supplied drugs.
Joseph Moscato, chief executive of Generex, a Florida-based biotechnology firm, says his parallel vaccine will “easily” get halal approval because “it is completely synthetic; there are no parts of [the vaccine payload] that could be in doubt”.
Generex's Ii-Key drug centres on synthetic antigenic peptides that are delivered through simple amino acids. Put simply, these peptides “supercharge the immune system, and don’t use messenger RNA [mRNA] like other vaccines,” Moscato told Salaam Gateway.
mRNA is a single-stranded molecule of RNA that is complementary to one of the DNA strands of a gene. It is made from cell cultures that may contain non-halal materials.
“In the next 30 days, I would say we will have a safe, effective, long-term memory vaccine with a simple composition of amino acids. We don’t put any of the stuff that these other guys put in that would prohibit them from getting halal certification,” said Moscato, referring to some of Malaysia’s official vaccines that use mRNA.
IS HALAL CERTIFICATION NEEDED?
There is currently some confusion about whether all the vaccines sourced by the Malaysian government will be halal or halal-certified. Khairy Jamaluddin, the minister responsible for their roll-out, which is expected to begin before the end of February, said the government will follow in neighbouring Indonesia’s footsteps and verify the halal status of one of its vaccines, by China’s Sinovac, which will be manufactured in Malaysia.
However, health ministry director-general Noor Hisham Abdullah previously suggested that there would be no need for vaccines to be certified halal.
“If they can get the halal certification, that would be better, but we do not register medicine based on halal status or not. We do register non-halal medicine too," he told Singapore’s Straits Times last month. So far, the Sinovac vaccine is the only one in the world to have been certified halal.
MALAYSIA’S VACCINE OPTIONS
Malaysia’s roll-out will begin with the first of 12.7 million doses already ordered from Pfizer-BioNtech.
This will be followed by 14 million Sinovac doses, as well as 6.4 million doses from the World Health Organisation's COVAX facility and another 6.4 million from AstraZeneca/Oxford. The last one is the only government-ordered vaccine that does not use mRNA, and is single-dose.
Generex and China’s Anhui Zhifei Longcom Biopharmaceutical have both signed distribution agreements for their parallel vaccines with Malaysian companies Bintai Kinden and MYEG, respectively. The Anhui Zhifei drug also expects to obtain halal certification. Both are currently in late-stage trials.
In addition, Bintai Kinden has exclusive rights to distribute, sell and commercialise Generex’s Ii-Key vaccine in Southeast Asia. The company has also been given the first right of refusal to distribute and market the vaccine within Australia, New Zealand and the global halal market, it says. Bintai Kinden, which is better known as an engineering corporation, declined Salaam Gateway’s request for comment.
PARALLEL VACCINES AND APPROVAL PROCESS
Though there is still little public awareness about these parallel vaccines, they are being just as rigorously assessed as all other approved medicines on the market and will play an important role in the national vaccination effort.
“The COVID-19 pandemic is probably the first time that health systems have had to quickly vaccinate an entire population all at once. That means we do not have a playbook to govern how the public and private sectors can interact in delivering such a vaccination programme,” Dr. Khor Swee Kheng, a Malaysian physician and health policy specialist, told Salaam Gateway.
All vaccines must go through the regulatory approval process in countries where they are meant for use.
“That process is based on accepted international scientific standards, which may not contain a halal requirement. To facilitate the approval of halal vaccines using the existing scientific regulatory pathway, regulatory agencies in relevant countries may need to consider updating or harmonising their scientific and halal approval processes,” he added.
Amrahi Buang, president of the Malaysian Pharmacists Society, stressed the importance of giving people options for their preference of vaccines, and especially halal-certified shots.
“Malaysia practices on the free market. It means that anyone can bring their product in and they will be given the same regulatory process,” Amrahi told Salaam Gateway.
“When you look at the global population, there is no one company that is able to produce vaccine for everyone, so we are talking about various types of vaccines. People can make their own choice about the technology behind their vaccines. For example, if they are afraid about the mRNA technology, then they can still use other approaches."
Any company wanting to distribute their vaccine in Malaysia would have to present its dossier to the country’s National Pharmaceutical Regulatory Agency, which then assesses it for quality, safety and efficacy.
GENEREX II-KEY VS. mRNA VACCINES
Through the partnership with Bintai Kinden, clinical trials of Ii-Key are currently being conducted in the United States on behalf of Malaysian regulators under the auspices of the Food and Drug Administration (FDA) there.
“If [the Malaysian regulators] find out that the thing is okay, then they will bring it onto the market. I'm sure it will be given the same treatment that will be given to Pfizer or to AstraZeneca,” said Amrahi.
“What we know is they are not using the Malaysian population [for the trials], though that’s not to say that the thing is not effective. But we have different races, and we need to consider such things. After that, we can find out whether it is halal or not—certification in Malaysia has to follow the MS2424:2019 standard.”
The Generex drug was developed using established biotechnology from its work in developing cancer drugs, for which it is best known. Since there is already a body of evidence to support the safety of its approach, some regulatory tests are not needed, potentially bringing it to market faster.
“We have lots of data from our cancer work showing that Ii-Key vaccines do not cause adverse events in patients. We have a very clear safety profile, as recognised by the FDA. The FDA confirmed that we didn’t need to do animal studies at all for toxicology. That has saved us six months,” said Moscato.
At the same time, he is critical of the long-term safety and efficacy of the government-sourced vaccines, voicing astonishment that they have not been more thoroughly vetted.
For example, Moscato believes that safety issues can arise when pharmaceutical companies use live attenuated vaccines that are soaked in formaldehyde to inactivate them. If a patient happens to get a live virus in their jab, then disease might follow. This, however, is contrary to the views of the U.S. Centres of Disease Control and Prevention, though it has yet to be established in practice in approved vaccines.
Moreover, the spike proteins in a coronavirus infection—the lumps on the virus particle’s surface that form the corona appearance that gives it its name—provide the surface targets of most vaccines. Though these trigger the production of 1,800 antibodies against COVID-19, only nine of them neutralise the virus, and these provide the peptide epitopes that Generex’s Ii-Key vaccine draws from. The remaining 1,791 antibodies ignited by other vaccines could potentially cause off-target reactions,” Moscato asserts.
Since it is possible—likely, Moscato believes—that the mRNA vaccines will only provide short-term immunity, these triggered antibodies could become problematic over time.
“Since last February, we knew that the virus would never get long-term immunity. We believe it will be like flu, whereby you might get it over and over again over time,” he said.
“Ii-Key does offer long-term memory, as has been shown in our cancer drugs, but if you keep having to get vaccinated with other vaccines, the wrong antibodies will build up. That can create bad effects.
“That’s when your immune system starts attacking your own body. No one is talking about that. We can’t understand why nobody is talking about the serious harmful effects of mRNA vaccines will do six months to a year after vaccination. That’s the big problem,” he added.
A peer-reviewed study by T.F. Rogers et al supporting Generex’s nine neutralising antibodies was conducted last year and published in June in the journal Science.
GENEREX CLAIMS ‘CREDIBLE’ BUT mRNA SAFE
Amrahi Buang says Generex’s claims are credible, but also stresses that the mRNA vaccines approved by the government are safe for purpose.
“The study of mRNA is not new, it’s been going on for three decades already. At the end of the day, it will produce the spike protein, the cell wall will give out antibodies and when an invader enters the body, they will be able to detect it. The mRNA is like a big “Wanted” poster for the body,” he said.
“We are all carrying out pharmacovigilance. Safety is our concern and all governments are alert to make sure that when a vaccine is given to the public, it is safe.
“What we are facing now is unprecedented. Never in our history have we had to vaccinate billions; it’s a massive exercise,” he added.
The Malaysian government is also at pains to state that the vaccines it has ordered, and any others that go through its regulatory approval process, will work and not have adverse effects.
As Khairy Jamaluddin, who is minister of science, technology and innovation and co-chair of a special committee ensuring access to COVID-19 vaccine supply, wrote recently in his update on vaccine procurement: “I want to assure you that we will only get vaccines that are safe and efficacious for Malaysians.”
His deputy minister, Ahmad Amzad Hashim, went further. “All vaccines have side-effects; what is important is that the side-effects are not serious or harmful. So far, based on the data we received, the [Pfizer-BioNtech] vaccine does not have serious side-effects.
“Most side-effects are temporary, such as injection pain; some may have fever or nausea,” he told Malaysia's state news agency Bernama.
HALAL ISSUES WITH GENEREX COVID-19 VACCINE
Generex asserts that the vaccine “payload” it has developed is synthetic, and therefore intrinsically halal. However, the third-party adjuvant may require some discussion with halal authorities.
An adjuvant is a companion to the payload used to improve the immune response to a vaccine. The one chosen by Generex has been developed by global conglomerate 3M.
During the very early stages of research and development of the adjuvant, 3M conducted studies involving human embryonic kidney cells, which were derived from an immortalised cell line and not harvested directly from embryos.
Since Malaysian halal standard MS2424:2019 prohibits the use of najs (ritually unclean material) in pharmaceuticals, the adjuvant may be flagged during the certification process, though Amrahi Buang, who was part of the group that devised the standard, calls its use a “grey area” that will require discussion.
“My view is that there is a solution to this. We can use either the istihalah concept or the istihlak concept. The first means the substance has undergone a transformation process that results in a halal finished product. The other means there has been heavy dilution,” he said.
In this way, a quantity of prohibited substance is reduced over time so that none of the known properties of the original are noticeable. In effect, its haram-ness will have been diluted out of it.
“It depends on what view the religious body will take. That’s why it’s very important for the manufacturer to outline all the details of the product. I cannot say yes and I cannot say no,” Amrahi added.
If the adjuvant went on to prevent Generex from securing halal approval for its vaccine, the company would look at different ways to assure its halal-ness.
“We selected the adjuvant because it is very specific to the needs of our vaccine. Our option would then be to find some way to substitute the prohibited ingredients, which I would speak to the 3M formulators about, or to find an alternative adjuvant,” Generex’s chief medical officer, Dr. Jason Terrell, told Salaam Gateway.
“This would be possible, but if you change the adjuvant, then theoretically we would have to repeat the clinical trial, which is something that nobody wants. We will cross that bridge if we get there.”
(Reporting by Richard Whitehead; Editing by Emmy Abdul Alim emmy.abdulalim@salaamgateway.com)
*Correction: The Malaysian Pharmaceutical Society was changed to Malaysian Pharmacists Society to reflect is recent name change.
© SalaamGateway.com 2021 All Rights Reserved
Author Profile Image
BY RICHARD WHITEHEAD
25 JAN 2021
NEWS
SALAAM GATEWAY
KUALA LUMPUR - While little is known yet about the halal status of all the official coronavirus vaccines Malaysia will distribute this year, other vaccines that will be certified halal are still expected to be available.
These parallel vaccines will be ordered by physicians at the request of their patients. The public may ask for these drugs for various reasons, including beating the queue for vaccination and doubts over the safety—or halal-ness—of government-supplied drugs.
Joseph Moscato, chief executive of Generex, a Florida-based biotechnology firm, says his parallel vaccine will “easily” get halal approval because “it is completely synthetic; there are no parts of [the vaccine payload] that could be in doubt”.
Generex's Ii-Key drug centres on synthetic antigenic peptides that are delivered through simple amino acids. Put simply, these peptides “supercharge the immune system, and don’t use messenger RNA [mRNA] like other vaccines,” Moscato told Salaam Gateway.
mRNA is a single-stranded molecule of RNA that is complementary to one of the DNA strands of a gene. It is made from cell cultures that may contain non-halal materials.
“In the next 30 days, I would say we will have a safe, effective, long-term memory vaccine with a simple composition of amino acids. We don’t put any of the stuff that these other guys put in that would prohibit them from getting halal certification,” said Moscato, referring to some of Malaysia’s official vaccines that use mRNA.
IS HALAL CERTIFICATION NEEDED?
There is currently some confusion about whether all the vaccines sourced by the Malaysian government will be halal or halal-certified. Khairy Jamaluddin, the minister responsible for their roll-out, which is expected to begin before the end of February, said the government will follow in neighbouring Indonesia’s footsteps and verify the halal status of one of its vaccines, by China’s Sinovac, which will be manufactured in Malaysia.
However, health ministry director-general Noor Hisham Abdullah previously suggested that there would be no need for vaccines to be certified halal.
“If they can get the halal certification, that would be better, but we do not register medicine based on halal status or not. We do register non-halal medicine too," he told Singapore’s Straits Times last month. So far, the Sinovac vaccine is the only one in the world to have been certified halal.
MALAYSIA’S VACCINE OPTIONS
Malaysia’s roll-out will begin with the first of 12.7 million doses already ordered from Pfizer-BioNtech.
This will be followed by 14 million Sinovac doses, as well as 6.4 million doses from the World Health Organisation's COVAX facility and another 6.4 million from AstraZeneca/Oxford. The last one is the only government-ordered vaccine that does not use mRNA, and is single-dose.
Generex and China’s Anhui Zhifei Longcom Biopharmaceutical have both signed distribution agreements for their parallel vaccines with Malaysian companies Bintai Kinden and MYEG, respectively. The Anhui Zhifei drug also expects to obtain halal certification. Both are currently in late-stage trials.
In addition, Bintai Kinden has exclusive rights to distribute, sell and commercialise Generex’s Ii-Key vaccine in Southeast Asia. The company has also been given the first right of refusal to distribute and market the vaccine within Australia, New Zealand and the global halal market, it says. Bintai Kinden, which is better known as an engineering corporation, declined Salaam Gateway’s request for comment.
PARALLEL VACCINES AND APPROVAL PROCESS
Though there is still little public awareness about these parallel vaccines, they are being just as rigorously assessed as all other approved medicines on the market and will play an important role in the national vaccination effort.
“The COVID-19 pandemic is probably the first time that health systems have had to quickly vaccinate an entire population all at once. That means we do not have a playbook to govern how the public and private sectors can interact in delivering such a vaccination programme,” Dr. Khor Swee Kheng, a Malaysian physician and health policy specialist, told Salaam Gateway.
All vaccines must go through the regulatory approval process in countries where they are meant for use.
“That process is based on accepted international scientific standards, which may not contain a halal requirement. To facilitate the approval of halal vaccines using the existing scientific regulatory pathway, regulatory agencies in relevant countries may need to consider updating or harmonising their scientific and halal approval processes,” he added.
Amrahi Buang, president of the Malaysian Pharmacists Society, stressed the importance of giving people options for their preference of vaccines, and especially halal-certified shots.
“Malaysia practices on the free market. It means that anyone can bring their product in and they will be given the same regulatory process,” Amrahi told Salaam Gateway.
“When you look at the global population, there is no one company that is able to produce vaccine for everyone, so we are talking about various types of vaccines. People can make their own choice about the technology behind their vaccines. For example, if they are afraid about the mRNA technology, then they can still use other approaches."
Any company wanting to distribute their vaccine in Malaysia would have to present its dossier to the country’s National Pharmaceutical Regulatory Agency, which then assesses it for quality, safety and efficacy.
GENEREX II-KEY VS. mRNA VACCINES
Through the partnership with Bintai Kinden, clinical trials of Ii-Key are currently being conducted in the United States on behalf of Malaysian regulators under the auspices of the Food and Drug Administration (FDA) there.
“If [the Malaysian regulators] find out that the thing is okay, then they will bring it onto the market. I'm sure it will be given the same treatment that will be given to Pfizer or to AstraZeneca,” said Amrahi.
“What we know is they are not using the Malaysian population [for the trials], though that’s not to say that the thing is not effective. But we have different races, and we need to consider such things. After that, we can find out whether it is halal or not—certification in Malaysia has to follow the MS2424:2019 standard.”
The Generex drug was developed using established biotechnology from its work in developing cancer drugs, for which it is best known. Since there is already a body of evidence to support the safety of its approach, some regulatory tests are not needed, potentially bringing it to market faster.
“We have lots of data from our cancer work showing that Ii-Key vaccines do not cause adverse events in patients. We have a very clear safety profile, as recognised by the FDA. The FDA confirmed that we didn’t need to do animal studies at all for toxicology. That has saved us six months,” said Moscato.
At the same time, he is critical of the long-term safety and efficacy of the government-sourced vaccines, voicing astonishment that they have not been more thoroughly vetted.
For example, Moscato believes that safety issues can arise when pharmaceutical companies use live attenuated vaccines that are soaked in formaldehyde to inactivate them. If a patient happens to get a live virus in their jab, then disease might follow. This, however, is contrary to the views of the U.S. Centres of Disease Control and Prevention, though it has yet to be established in practice in approved vaccines.
Moreover, the spike proteins in a coronavirus infection—the lumps on the virus particle’s surface that form the corona appearance that gives it its name—provide the surface targets of most vaccines. Though these trigger the production of 1,800 antibodies against COVID-19, only nine of them neutralise the virus, and these provide the peptide epitopes that Generex’s Ii-Key vaccine draws from. The remaining 1,791 antibodies ignited by other vaccines could potentially cause off-target reactions,” Moscato asserts.
Since it is possible—likely, Moscato believes—that the mRNA vaccines will only provide short-term immunity, these triggered antibodies could become problematic over time.
“Since last February, we knew that the virus would never get long-term immunity. We believe it will be like flu, whereby you might get it over and over again over time,” he said.
“Ii-Key does offer long-term memory, as has been shown in our cancer drugs, but if you keep having to get vaccinated with other vaccines, the wrong antibodies will build up. That can create bad effects.
“That’s when your immune system starts attacking your own body. No one is talking about that. We can’t understand why nobody is talking about the serious harmful effects of mRNA vaccines will do six months to a year after vaccination. That’s the big problem,” he added.
A peer-reviewed study by T.F. Rogers et al supporting Generex’s nine neutralising antibodies was conducted last year and published in June in the journal Science.
GENEREX CLAIMS ‘CREDIBLE’ BUT mRNA SAFE
Amrahi Buang says Generex’s claims are credible, but also stresses that the mRNA vaccines approved by the government are safe for purpose.
“The study of mRNA is not new, it’s been going on for three decades already. At the end of the day, it will produce the spike protein, the cell wall will give out antibodies and when an invader enters the body, they will be able to detect it. The mRNA is like a big “Wanted” poster for the body,” he said.
“We are all carrying out pharmacovigilance. Safety is our concern and all governments are alert to make sure that when a vaccine is given to the public, it is safe.
“What we are facing now is unprecedented. Never in our history have we had to vaccinate billions; it’s a massive exercise,” he added.
The Malaysian government is also at pains to state that the vaccines it has ordered, and any others that go through its regulatory approval process, will work and not have adverse effects.
As Khairy Jamaluddin, who is minister of science, technology and innovation and co-chair of a special committee ensuring access to COVID-19 vaccine supply, wrote recently in his update on vaccine procurement: “I want to assure you that we will only get vaccines that are safe and efficacious for Malaysians.”
His deputy minister, Ahmad Amzad Hashim, went further. “All vaccines have side-effects; what is important is that the side-effects are not serious or harmful. So far, based on the data we received, the [Pfizer-BioNtech] vaccine does not have serious side-effects.
“Most side-effects are temporary, such as injection pain; some may have fever or nausea,” he told Malaysia's state news agency Bernama.
HALAL ISSUES WITH GENEREX COVID-19 VACCINE
Generex asserts that the vaccine “payload” it has developed is synthetic, and therefore intrinsically halal. However, the third-party adjuvant may require some discussion with halal authorities.
An adjuvant is a companion to the payload used to improve the immune response to a vaccine. The one chosen by Generex has been developed by global conglomerate 3M.
During the very early stages of research and development of the adjuvant, 3M conducted studies involving human embryonic kidney cells, which were derived from an immortalised cell line and not harvested directly from embryos.
Since Malaysian halal standard MS2424:2019 prohibits the use of najs (ritually unclean material) in pharmaceuticals, the adjuvant may be flagged during the certification process, though Amrahi Buang, who was part of the group that devised the standard, calls its use a “grey area” that will require discussion.
“My view is that there is a solution to this. We can use either the istihalah concept or the istihlak concept. The first means the substance has undergone a transformation process that results in a halal finished product. The other means there has been heavy dilution,” he said.
In this way, a quantity of prohibited substance is reduced over time so that none of the known properties of the original are noticeable. In effect, its haram-ness will have been diluted out of it.
“It depends on what view the religious body will take. That’s why it’s very important for the manufacturer to outline all the details of the product. I cannot say yes and I cannot say no,” Amrahi added.
If the adjuvant went on to prevent Generex from securing halal approval for its vaccine, the company would look at different ways to assure its halal-ness.
“We selected the adjuvant because it is very specific to the needs of our vaccine. Our option would then be to find some way to substitute the prohibited ingredients, which I would speak to the 3M formulators about, or to find an alternative adjuvant,” Generex’s chief medical officer, Dr. Jason Terrell, told Salaam Gateway.
“This would be possible, but if you change the adjuvant, then theoretically we would have to repeat the clinical trial, which is something that nobody wants. We will cross that bridge if we get there.”
(Reporting by Richard Whitehead; Editing by Emmy Abdul Alim emmy.abdulalim@salaamgateway.com)
*Correction: The Malaysian Pharmaceutical Society was changed to Malaysian Pharmacists Society to reflect is recent name change.
© SalaamGateway.com 2021 All Rights Reserved
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