Is the Vaccine Shortcut Safe?
The government has made a statement that Covid-19 vaccines will be available in November-December 2020 and vaccination will soon begin.
President Joko Widodo chaired a limited meeting regarding the preparation of the Covid-19 vaccine at the Merdeka Palace, Jakarta, Monday (26/10/2020).
The government has made a statement that Covid-19 vaccines will be available in November-December 2020 and vaccination will soon begin.
This was stated by Coordinating Maritime Affairs and Investment Minister Luhut Binsar Pandjaitan, concurrently Deputy Chairman of the Covid-19 Control and National Economic Recovery Committee. The government has set the target of vaccinating 100 million people in December 2020-January 2021. The vaccines are expected to be obtained from G42 company based in Abu Dhabi, which will total 30 million units, and the remainder will come from Sinovac, China.
At the same time, President Joko Widodo ordered that a detailed plan for vaccination be immediately drawn up. The Health Ministry responded. The Directorate General of Disease Prevention and Control (P2P), Health Ministry, has prepared a Grand Design/Road Map for Covid-19 Vaccination covering the number of vaccines needed, the aim, scheme and target of vaccination, including technical directives.
Also read: Anticipating Covid-19 Vaccine
The above developments indicate that the program for vaccination will be realized. However, it is realistic that vaccination can be carried out soon?
Vaccine testing
All Covid-19 vaccine candidates have to undergo tight efficacy and safety tests. This process is meant to guarantee that the vaccines are really safe and effective. In general, these tests cover preclinical trials, phase 1 to phase 3 clinical trials and post-marketing surveillance. The production of vaccines takes 10-15 years on average. The vaccine ever produced within the shortest time is that against mumps, taking four years. But due to the consideration of urgent need, experts have agreed to shorten the Covid-19 vaccine testing time to only 12-18 months.
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At present, more than 200 vaccine projects are underway all over the world. Of the total projects, 31 are already in the clinical trial phase, eight of which have entered phase 3 clinical trials. It means that in the next few months the clinical trial reports of some vaccines can be examined.
Syringes of SARS CoV-2 Vaccine for COVID-19 produced by SinoVac are displayed during a media tour of its factory in Beijing on Thursday, Sept. 24, 2020. A Chinese health official said Friday, Sept. 25, 2020, that the country\'s annual production capacity for coronavirus vaccines will top 1 billion doses next year, following an aggressive government support program for construction of new factories.
Pfizer claimed that the clinical trial report of its vaccine would be released at the end of October, while Moderna claimed it could report its trial result at the end of November. But the claims of both vaccine companies are doubted by some experts.
The WHO itself has estimated that vaccine clinical trial reports will only be obtained in December 2020 or January 2021. After reports are received, the regulatory approval body of each country will review the reports and decide on its approval or rejection. Only if approved can vaccines be manufactured. By this process, vaccines can hopefully be utilized by the public in the middle of 2021.
Indonesia becomes one of the countries for Sinovac vaccine clinical trials. Today around 1,200 people are participating in this testing. About 400 of them have received the second vaccination and later will be subjected to blood tests to determine the degree of vaccine safety. The report of its safety will be attained at the end of January 2021, while its efficacy can only be reported in March 2021.
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If the safety and efficacy reports are approved, it will take several months for Biofarma to produce the vaccine, excluding its distribution and the realization of vaccination. By applying the normal procedure as described above, the possibility of executing vaccination in December this year is slim.
Emergency use authorization
Apart from the normal path, a number of countries choose the fast-track route in the Covid-19 vaccine trial and production process. This shortcut is referred to as emergency use authorization (EUA), which is a hastened approval based on urgent need.
Also read : Waiting for COVID-19 Vaccine
The EUA constitutes a special license or approval. Based on the presence of emergency and crisis, an approval can be granted to drugs, substances or certain medical equipment although they have not yet fully gone through standard testing. This is meant to promptly make available the stuffs needed to overcome a crisis.
In America, the U.S. Food and Drug Administration (FDA) is allowed to apply this principle in the case of public health emergency. To this end, three criteria must be fulfilled, which are the presence of a serious and major threat to public health such as death; the presence of scientific evidence that the materials to be approved are effective and have greater benefits than disadvantages; and no alternatives are yet available for use to overcome the threat of serious disease. If the three criteria are met, sponsors can propose the EUA for the materials.
In Amerika quite a lot of materials have been approved through the EUA door. Various medical products like ventilators, personal protective equipment, serologic tests and remdesivir drug have been OK’d via the EUA. Even the antimalaria drugs hydroxychloroquine and chloroquine were permitted for use to treat Covid-19 through the EUA although the approval was finally canceled after various studies reported the serious side effects of the medicines.
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Among the materials that can secure EUA approval are Covid-19 vaccines. Although no Covid-19 vaccines have as yet been approved through the EUA, the FDA has suggested that vaccines already in phase 3 trials can have their EUA permission considered.
China and Russia even have long granted their EUA approvals to their Covid-19 vaccines. China’s CanSino vaccine has been approved for use among military circles since June 2020, while Russia’s Sputnik-V vaccine was allowed to be used in August 2020. Both vaccines were approved even before they entered phase 3 clinical trials. In the United Arab Emirates, the Covid-19 vaccine from Sinopharm was recently also granted an EUA approval for use among health workers.
Pros and cons
In some statements the government has suggested the utilization of a vaccine supply shortcut, which is through the EUA door. It means that the government doesn’t wait until all clinical trial phases are finished. The government may work in coordination with the Food and Drug Monitoring Agency (BPOM) to secure the EUA status for the vaccines to be imported from China and Abu Dhabi.
Also read: Waiting For Completion Of All Clinical Trial Stages
Despite the government’s strong influence to acquire the EUA status, various conditions should be given thoughtful considerations. First, the safety of vaccines that have not yet passed all phases of clinical trials remains unconfirmed.
Sinovac Biotech vaccines, one of 11 Chinese companies approved to carry out clinical trials of potential coronavirus vaccines, are displayed at a press conference during a media tour of a new factory built to produce Covid-19 coronavirus vaccines, in Beijing on September 24, 2020.
One of the aims of phase 3 clinical trials, for instance, is to detect the presence of possible side effects in one of several thousands of vaccine recipients. If this phase is not followed, the apparently “rare” side effects won’t be detected. In fact, when extrapolated to the population of vaccine users, the side effects that seem “rare” can grow into a large number. Let’s say that, in the absence of phase 3 trials, a vaccine side effect that emerges in one of 10,000 recipients is not detected. When vaccination is given to 260 million people, the side effects will appear in 260,000 vaccine recipients.
Second, unless all phases of clinical trials are followed, vaccine efficacy is difficult to extrapolate to the general public. In phase 3 clinical trials, the tests involve a vast population with different age groups, ethnic communities and health conditions. This is unlike phase 1 and phase 2 trials, which move involve healthy people. It means that without phase 3 trials, it’s hard to say that the vaccine’s efficacy is confirmed for all types of people, including those aged above 55 and having comorbidity that constitute a Covid-19 high-risk group. Giving vaccines with unconfirmed efficacy has the potential for the creation of pseudo-control.
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Third, in various countries permitting vaccines through the EUA, the vaccines are only given to certain population groups in limited numbers. Among others, they are only given to military personnel or frontline health workers. Thus, the general public is not allotted. It’s even on the condition that if any deficiency or serious side effect is found out, the vaccines’ approvals will be revoked.
Fourth, even if the EUA door is open to Covid-19 vaccines, the regulatory bodies of various countries apply tough principles. In America, the FDA refers to the EUA for Covid-19 vaccines as EUA-plus, with tighter criteria than the EUA for other medical products. Among others, vaccines must have at least 2 months’ follow-up after the second dose is given in phase 3 and have minimum efficacy of 50 percent. With such strict criteria, it’s not easy for a Covid-19 vaccine to earn the EUA.
Iqbal Mochtar
The EUA approval of vaccine utilization is indeed one of the alternatives during a period of crisis. Yet this option bears significant health and safety risks. The government should give it a clear thought before deciding whether vaccines will be used via the EUA shortcut with all the risks or the vaccine program will be postponed for several months with minimum and controlled risks.
Iqbal Mochtar, Doctor and Observer of Health Issues
