#AllYouNeedToKnow: Sputnik V

Photos from Gamaleya Center
Photos from Gamaleya Center

ON OCTOBER 4, 1957, Sputnik 1 was launched by the Soviet Union into the Earth's orbit making it the world's first artificial satellite.

On August 11, 2020, another Sputnik has made a mark in world history. However, this time it is not an artificial satellite. On this date, Sputnik V was registered by the Russian Ministry of Health making it the first registered coronavirus disease 2019 (Covid-19) vaccine on the market.

Sputnik V, developed by the Gamaleya National Research Institute of Epidemiology and Microbiology (Gamaleya Center), is among the over a hundred vaccines being developed by scientists and medical community in response to the Covid-19 pandemic.

However, despite being ahead of the pack, there are still skepticisms from the scientific community due to how fast the Russian institute was able to develop a vaccine in a short amount of time.

Dr. Alexander Gintsburg, Director of Gamaleya Center and Academician of the Russian Academy of Sciences, said they were able to develop Sputnik V quickly due to the availability of an existing technology and utilizing what they have learned from their existing vaccine project: vaccine for the Middle East Respiratory Virus (MERS).

MERS-CoV, which causes MERS, and the Sars-CoV-2, which causes the Covid-19, are coronaviruses.

"Work on the MERS vaccine enabled us to quickly and efficiently come up with Sputnik V and have it registered," Gintsburg said in an online briefing with the foreign press on August 20, 2020.

He said the team working on the MERS vaccine are also the ones who are working on the creation of the Covid-19 vaccine. Hence, causing a temporary delay on the MERS vaccine.

Technology

The Sputnik V is an adenoviral vector-based vaccine.

According to the official Sputnik V website, "vectors" are vehicle that can induce a genetic material from another virus into a cell.

"The gene from adenovirus, which causes the infection, is removed while a gene with the code of a protein from another virus spike is inserted. This inserted element is safe for the body but still helps the immune system to react and produce antibodies, which protect us from the infection," reads the description on the website, sputnikvaccine.com.

Adenoviruses are pathogens that commonly cause fever or coughs. In the development of the Covid-19 vaccine, the adenovirus has been genetically engineered to combat the coronavirus.

Aside from the Gamaleya Center, other manufacturers using the adenoviral-vector technology to develop a Covid-19 vaccine are CanSino Biologics, Johnson & Johnson, and the University of Oxford.

Gintsburg said the use of the adenovirus vector is nothing new. It is a technology that the research center has been developing since the 1980s. It is the same technology that they used to develop three vaccines against Ebola fever. All three are approved for use by the Russian Health Ministry.

He said after monitoring some 2,000 volunteers in the Republic of Guinea and Russians engaged in the country, they saw that an adenoviral vector-based vaccine was able to create a proactive immune response to those who were given the Ebola vaccine.

According to the Centers for Disease Control (CDC), adenovirus vaccines are also being used in the U.S. Army but it is currently not available to the public.

"Adenoviral vectors are considered extremely safe, and are some of the easiest to engineer. Vectors are viruses that have had the gene responsible for replication removed. Therefore, they no longer pose any threat of infection. Scientists use vectors to transport genetic material from a different virus - the one that is being vaccineated against - into a human cell," the Sputnik V website states.

Dr. Denis Logunov, Deputy Director for scientific work of Gamaleya Center and Correspondeming member of the Russian Academy of Sciences, said Sputnik V is a two-vector vaccine, which sets it apart from other Covid-19 vaccines that are adenoviral vector-based. The first vector is based on the adenovirus 26th serotype and the second is the 5th serotype.

"Both components are administered one after another," he said. The second component of the vaccine is given after 21 days.

Gintsburg said administering the vaccine twice is called a booster vaccination method. Through this method, those who are vaccinated with Sputnik V will be able to have a stronger immune response to the virus.

"We see from the research that two injections will provide for a long term immunity and many companies have decided focus on this approach," Logunov said.

He cited the study of AstraZeneca, a British multinational pharmaceutical and biopharmaceutical company that is also developing a Covid-19 vaccine.

"AstraZeneca has demonstrated that out of the 1,000 participants in the first and second phase, they provided two injections to only 10 participants. Those 10 participants received four times more antibodies compared to those who had only one injection," Logunov said.

The Gamaleya Center has also developed two forms of the vaccine.

First is the fluid form that is stored in -20 degrees Celcius and the second is lyophilized form that can be stored in temperatures of 4 degrees Celcius.

Both Logonov and Gintsburg assures that the use of human adenovirus for the development of vaccine is a safe technology. Both cited how it is a well-studied technology that has been used and tested on many people.

It was also stated on the website of Sputnik V that there are more than 350 scientific studies available worldwide on adenovirus vectors.

"This is not just another vaccine, it is a modern generation vaccine. It was developed on the basis of the latest achievements of molecular biology, virology and immunology, which means that it is an evidence-based vaccine. Even though the post-registration clinical trials are only starting now, we already know today that the vaccine gives a good immune response or develops antibodies. It also gives a good cellular response and most importantly is harmless. The vaccine registration was perfectly justified, and I think it will be the first effective medication - it has everything [to become one]," Russian health ministry Rakhim Khaitov was quoted saying in an August 27 report by TASS, a Russian state-owned news agency.

Clinical trials

Logonov said they have already completed their pre-clinical trials on the fluidized and lyophilized (freeze-dry) forms of the vaccine on non-human projects.

The vaccines were tested on hamsters, mice, rats, guinea pigs, rabbits, and two types of primates -- rhesus monkey and marmosets. Researchers used different models for the testing of the vaccine.

"The vaccine has demonstrated high safety profile and were assessed highly by the Ministry of Health," Logonov said.

He said based on the research, the tests done on the primates have not demonstrated any Antibody-dependent enhancement impacts.

"All the vaccinated primates were fully protected and no damage were inflicted on their lungs," Logonov added.

During the Phase 1 and 2 clinical trials, they also tested the fluidized and lyophilized forms on healthy volunteers who are 18 to 60 years old.

According to ClinicalTrials.gov of the U.S. National Library of Medicine, clinical trials for Sputnik V were done on June 17, 2020 and was completed on August 10, 2020. A total of 38 participants were tested using the fluidized form and another 38 for the lyophilized form.

According to the website, Gamaleya Center has not yet posted its results.

However, Logonov said based on their clinical trials, results were promising.

"There was a very good profile of safety, not a single side effect was registered," Logonov said.

He said they also assessed the efficacy of the vaccine in terms of immune response.

"We have demonstrated that 100 percent of volunteers have virus-neutralizing antibodies," Logonov said.

On August 11, the Russian Ministry of Health issued the vaccine's registration certificate "under emergency rules adopted during the Covid-19 pandemic."

"Clinical Phase 1 and 2 have shown that 100 percent of volunteers received a very strong immune response," Logonov said.

On August 24, post-registration clinical trials started.

"It will see 40,000 volunteers get vaccinated, while high-risk groups can get vaccinated simultaneously, primarily doctors and teachers," Khaitov said in the August 27 report of Tass.

The United Arab Emirates, Saudi Arabia, Philippines, and possibly India or Brazil are expected to join the clinical trials of Sputnik V.

Logonov said they are ready to supply vaccine to the external market in November after the mass vaccination in Russia that is eyed to begin in October.

PH-Russia cooperation

Russian Ambassador to the Philippines Igor Khovaev said in an online interview with SunStar Philippines on August 20 that Russia is offering Philippines several areas where the two nations can collaborate.

"While we welcome contributions from all the parties concerned, primarily we would like to develop “Sputnik V” in cooperation with our close partners like the Philippines," he said.

These areas of collaboration are: exchanging information on development and clinical trials of the Russian vaccine; conducting clinical trials of the vaccine on the Philippine soil in order to verify its efficiency and safety and to complete the relevant registration procedures in full compliance with the local legislation; supplying the vaccine to the Philippines; sharing technologies and manufacturing the vaccine on the Philippine territory.

"I am pleased to say that Russian and Philippine experts have already started exchanging opinions on the technical aspects of conducting the abovementioned trials in the Philippines," Khovaev said.

In an August 28 PTV report, Department of Science and Technology's panel of vaccine experts are now reviewing the documents on Sputnik V.

Philippines is presently part of the World Health Organization's solidarity trials on Covid-19 treatments. Dr. Jaime Montoya of the Philippine Council for Health Research and Development said in the report that there are also two vaccine developers planning to have clinical trials in the country too.

Khovaev said there is also the possibility that the vaccine could be locally produced in the Philippines.

"This transfer of technology will open up new horizons for bilateral economic and scientific cooperation because the technology in question can be used in a whole variety of fields. Not to mention that it will likely make the Philippines a regional hub for the anti-Covid-19 vaccine," Khovaev said.

President Rodrigo R. Duterte, during his August 11 public address, said the Philippines is ready to accept the offer of Russia on the vaccine.

"Kaya ngayon tinatanggap natin at kung ano ang supply mag-usap pa kami kung ilan ang supply at kailangan natin (We are ready accept their offer and we will discuss as to how much supply we will need)," he said.

The president also expressed high hopes for the Sputnik V.

"Sabihin ko rin kay President Putin na...malaki ang tiwala ko sa pag-aa-- (I will tell President Putin that I trust) your studies in combatting COVID and I believe that the vaccine that you have produced is really good for humanity," Duterte said.

The President also said he is willing to be administered with the Sputnik V first.

"Pagdating ng bakuna, in public, para walang satsat diyan magpa-injection ako. Ako yung maunang maeksperimentuhan. Okay para sa akin (When the vaccine arrives, I will volunteer and publicly be experimented with it first so people won't say anything)," Duterte said.

Khovaev said the Philippine government has been "enthusiastic" with their offer.

"Apart from that, we are getting a lot of positive feedback from Philippine parliamentarians and businesspeople. A lot of them are asking how they could help to expedite the process of bringing the vaccine to the Philippines," he said.

Skepticism

Despite the advancements the Gamaleya Center made, it is not without skepticism by the scientific and medical community.

“It’s a too early stage to truly assess whether it’s going to be effective, whether it’s going to work or not,” said Dr. Michael Head, senior research fellow in global health at England’s University of Southampton, in an Associated Press report on August 12.

Catherine Smallwood, a senior emergency official at the World Health Organization-Europe, said in a separate Associated Press report on August 20 that, "This concern that we have around safety and efficacy is not specifically for the Russia vaccine, it’s for all of the vaccines under development.”

She said it is important for vaccine manufacturers to not to cut corners in safety or efficacy.

“We’re not going through a rushed job of trying to jump to conclusions here...We want to take our time to really understand where the vaccine’s at and to get as full information as possible on the steps that have already been taken,” Smallwood said.

Khovaev said the skepticism from the medical community, especially from Western countries, is normal.

"On the one hand, I think it is normal because it is only human nature

to be skeptical towards something new... On the other hand, a fair share of the skepticism regarding the safety of the Russian vaccine is nothing but an attempt to undermine the results of the work of Russian scientists for political and commercial reasons," he said.

Currently, there are over a hundred Covid-19 vaccines that are being developed, including the Sputnik V. Each vaccine is on different phases of its trials.

While we wait, the development of the vaccine has given people a glimmer of hope amid the Covid-19 pandemic.

"Russia is indeed the first country to have developed and registered a working Covid-19 vaccine. We consider this not only the achievement of Russian scientists but also a major breakthrough for the entire world. The Covid-19 pandemic is an enemy that no single country big or small is able to defeat by itself. The pandemic can only be overcome by joining the efforts and resources of all responsible nations. This is why we are inviting partners and friends to participate in the final stages of development of the vaccine," Khovaev said.

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