Russia considers COVID-19 vaccination certificates for cross-border travels

MOSCOW (Reuters) – Russian President Vladimir Putin has ordered the government to consider issuing certificates to those who had been inoculated with domestic vaccines against COVID-19 for overseas travels, a document published by the Kremlin showed on Monday.

The document also said the government has been tasked with making the certificates internationally recognizable.

a fire hydrant in the middle of the night: Paramedics visit patients at home amid coronavirus disease (COVID-19) outbreak in Novgorod Region

© Reuters/ANTON VAGANOV
Paramedics visit patients at home amid coronavirus disease (COVID-19) outbreak in Novgorod Region

Russia, which has the world’s fourth highest number of COVID-19 cases, is putting high hopes on several domestically produced vaccines. It started wide-scale vaccination against the disease last month.

More than 800,000 people in Russia have been inoculated so far and more than 1.5 million vaccine doses have been dispatched, Health Minister Mikhail Murashko said on Saturday.

From Jan. 1, people who are inoculated in Russia will get an electronic vaccination certificate, the TASS news agency quoted Murashko as saying. The ministry is keeping a database of Russians who have been vaccinated, TASS reported.

Related Slideshow: Major COVID-19 vaccines – What to know (Provided by Photo Services)

Gallery

An intense race is on since the early days of the COVID-19 pandemic to find a vaccine to combat the coronavirus. A number of institutes and healthcare companies around the world are conducting tests faster than usual so as to bring a vaccine into the market by the end of 2020 or the first half of 2021. According to the U.S. Food and Drug Administration (FDA), a vaccine will be considered effective only if it is able to protect at least 50 percent of those vaccinated.

The information provided in this slideshow is updated as of Dec. 12, 2020.

Among the many vaccines that have been developed so far, a handful have entered Phase 3 trials, under which thousands are administered the vaccine and then studied over a period of time to see if they get infected and for side effects that may have been missed in the smaller phases. The vaccines in Phase 3 trials can be classified into four types – viral vector vaccines, genetic vaccines, inactivated or attenuated coronavirus vaccines and repurposed vaccines. Here’s a look at the vaccines in Phase 3.

Pfizer-BioNTech

A combined Phase 2/3 trial was launched on July 27 by Pfizer, based in New York, U.S., and Germany’s BioNTech for the vaccine called BNT162b2. The development came after it was proved that the mRNA vaccine produced fewer side effects than another version, BNT162b1, that was also being tested. Pre-clinical results of the BNT162b2, published on pre-print server bioRxiv, had showed that it had “protective anti-viral effects in rhesus macaques, with concomitant high neutralizing antibody titers and a TH1-biased cellular response in rhesus macaques and mice.” Phase 1/2 trials showed that it produced antibodies against SARS-CoV-2 as well as T cells.

The Phase 2/3 trials are being conducted on 44,000 people in countries such as the U.S., Germany and Brazil. The company aims to get regulatory approval before the end of 2020 and produce 1.3 billion doses by end of next year. In September, the U.S. government signed a $1.9 billion contract with Pfizer for the supply of 100 million doses by December 2020 if the drug is approved. Japan and European Union, too, have entered into their own agreements with the company for the delivery of millions of doses. On Sept. 13, Pfizer CEO Albert Bourla said in an interview with CBS’ Face the Nation that “we have a good chance that we will know if the product works by the end of October.” BioNTech is also collaborating on the vaccine with Chinese drug maker Fosun Pharma. On Nov. 9, the companies announced that their vaccine is “90 percent” effective against coronavirus. “Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis,” Pfizer said in a statement. On Nov. 18, the company announced that the final results from the late-stage trial showed that the vaccine was 95 percent effective. The company also said that it would apply for emergency U.S. authorization within days.

The U.K. gave emergency use approval to the vaccine on Dec. 2, becoming the first western country to grant such an approval to a vaccine. On Dec. 8, UK rolled out the mass vaccination program with 90-year-old Margaret Keenan becoming the first person to receive a jab. The U.S. on Dec. 11 gave the vaccine authorization for emergency use. U.S. President Donald Trump said that the first vaccinations will take place “in less than 24 hours.”

University of Oxford and AstraZeneca

One of the foremost candidates in the vaccine race, the AZD1222, which was previously known as ChAdOx1 nCoV-19, is another type of viral vector vaccine in which the invasive SARS-CoV-2 spike protein is transferred to a weakened version of common-cold-causing adenovirus from chimpanzees. When injected into the body, it is expected to trigger an immune response due to the presence of the spike protein. The vaccine is being developed by the university in U.K. in collaboration with the British-Swedish biopharmaceutical company.

The U.S. government invested $1.2 billion to support the development of the vaccine in May. Initial studies during Phase 1/2 trials indicate that the vaccine was able to provide protection to monkeys and was able to raise antibodies and responses from T-cells. Minor side-effects were also noted. The vaccine subsequently entered Phases 2/3 trials in India and England and Phase 3 trials in Brazil, South Africa and the U.S. In early September, AstraZeneca issued a statement saying that it had paused all trials “to allow an independent committee to review the safety data of a single event of an unexplained illness that occurred in the UK Phase III trial.” Trials were later resumed in most countries, including U.K., Japan and India, but are on hold in the U.S. On Nov. 23, the drugmaker announced that the vaccine was on an average 70.4 percent effective. The vaccine was found to be 90 percent effective when half a dose was administered first, followed by a full dose a month later. In late November an Indian volunteer sued the company and vaccine maker Serum Institute of India (SII) claiming adverse reactions due to the vaccine. The company called the charges “malicious and misconceived.” India’s health ministry later clarified that initial findings into the event did not call for a halt of the trials. On Dec. 7, SII’s CEO Adar Poonawalla said that the vaccine manufacturer has applied for emergency use authorization in India.

Moderna Therapeutics

The biotech company based in Massachusetts, U.S., developed the mRNA-1273 jointly with the National Institutes of Health, an agency of the U.S. Department of Health and Human Services. The mRNA-1273 is a genetic vaccine, which means that it injects snippets of the coronavirus’ own genes into human cells so that an immune response can be triggered. No vaccine of mRNA type has yet been brought into the market.

Human trials started in March, after its safety was ensured from trials conducted on animals. Phase 1 studies showed that healthy subjects, including elderly, produced coronavirus antibodies and a reaction from T-cells. On July 27, the vaccine, which requires two doses separated by four weeks, entered Phase 3 trials for which tests will be conducted on 30,000 participants from across the U.S. Funded by the U.S. government, the country has sought 100 million doses of the vaccine if it is proven safe. Canada, too, has agreed to buy 20 million doses. But according to The New York Times, the company’s chief executive Stéphane Bancel said in September that it is unlikely that the vaccine would be widely available in the first half of 2021. The company announced on Nov. 16 that data from the trial show its vaccine is 94.5 percent effective. On Dec. 1, a day after it sought emergency use approval from the U.S., the company approached the European Medicines Agency (EMA) with a similar request for European Union (E.U.).

Bharat Biotech

The Indian company is working on an inactivated vaccine candidate, named Covaxin, in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV). The Phase 1/2 studies commenced in July following approval from Drugs Controller General of India (DCGI). Results of the two phases were reported to be promising and Bharat Biotech said in a statement that there were no major adverse side effects.

DCGI’s Subject Expert Committee (SEC) recommended the granting of permission for Phase 3 trials in October after the company presented interim data of clinical trials of the first two phases. The Phase 3 trials were launched on Nov. 16 and will involve 26,000 volunteers from across the country – the largest for a COVID-19 vaccine in India. Volunteers will be randomly assigned to either of two groups: one that will receive the vaccine dose and another that will receive a placebo. They will receive two doses 28 days apart. According to Press Trust of India, Bharat Biotech applied for emergency use authorization for the vaccine in India on Dec. 7.

Sinovac

CoronaVac is another inactivated vaccine, which means that it is created from a non-infectious version of the coronavirus. The mechanism allows an immune response to be kicked in even if the pathogens do not produce a disease. Developed by China’s Sinovac Biotech in collaboration with Brazilian research center Butantan, the vaccine has been found to be able to produce antibodies for 10 strains of SARS-CoV-2 in Phase 1 trials conducted on macaque monkeys.

There were no severe reactions observed in the human trials conducted in Phase 2. Phase 3 trials were launched in July in Brazil, and later expanded into Indonesia, Bangladesh and Turkey. According to Reuters, the vaccine got approval from the Chinese government in July for limited use. Yin Weidong, the CEO of Sinovac, said in September that a worldwide distribution of the vaccine in early 2021 is being planned. The company has an agreement to deliver at least 40 million doses to Indonesia by March 2021.

Sinopharm

Like CoronaVac, the unnamed vaccine developed by the state-run China National Pharmaceutical Group (Sinopharm) along with Wuhan Institute of Biological Products (WIBP) is an inactivated vaccine. Sinopharm is also developing a second inactivated virus vaccine with the Beijing Institute of Biological Products (BIBP). According to China National Biotec Group (CNBG), a Sinopharm unit, there has been a “strong neutralizing antibody response” triggered by the vaccine in the Phase 1/2 trials. Antibody response was observed and no serious side effects were found in the two trials, according to JAMA Network. Phase 3 trials were launched in July in the UAE, followed by Peru and Morocco the next month.

The vaccine was the first to be administered to civilians (non-clinical volunteers) under the Chinese government’s emergency-use program, which was launched in July. Along with other vaccines being developed in China, the two Sinopharm vaccines have been used to inoculate hundreds of thousands so far. The New Yorker reported on Sept. 29 that according to Yiwu He, the chief innovation officer at the University of Hong Kong, over a hundred director-level Chinese Communist Party cadres and many executives at CNBG and Sinopharm have been vaccinated. According to the report, Sinopharm is filing for approval for the vaccine from China’s regulatory commission. The UAE granted approval for the use of Sinopharm vaccine on healthcare workers on Sept. 14. In late November, the company applied for regulatory approval to launch the vaccines. On Dec. 9, UAE’s health ministry said that the vaccine has 86 percent efficacy.

Gamaleya National Center of Epidemiology and Microbiology

Known as Sputnik V, the viral vector vaccine uses two strains of the adenoviruses – Ad5 and Ad26. Russia hadn’t initially published any data of the Phase 1 and 2 trials of the vaccine, which is being developed in partnership with state-run Russian Direct Investment Fund (RDIF). At the time the researchers said that the vaccine, which has to be injected a second time 21 days after the first, produced strong antibody and cellular immune responses during trials. Gamaleya eventually published the results on Sept. 4, in which researchers said that the vaccine yielded antibodies to the coronavirus and mild side effects in a small study.

Russian President Vladimir Putin announced on Aug. 11 that vaccine had been granted approval. According to AFP, Putin told government ministers in a televised call that “for the first time in the world, a vaccine against the new coronavirus was registered” in the country. “I know that it works quite effectively, forms strong immunity, and I repeat, it has passed all the needed checks,” said Putin, adding that one of his two daughters had received a dose. Following worldwide criticism over the announcement, the Russian government later said that the approval was a “conditional registration certificate” that made it obligatory to undergo Phase 3 trials. The trials, which were initially meant for 2,000 volunteers, were expanded to 40,000. On Oct. 8, it was reported that India, one of the countries with which Russia negotiated agreements to supply the vaccine, rejected a proposal for a large study of Sputnik V in the country. On Nov. 9, a representative of Russia’s health ministry said in a statement that the vaccine’s “effectiveness is also more than 90 percent.” Dr. Reddy’s Laboratories Ltd. (RDY) and Russian Direct Investment Fund announced on Dec. 1 that adaptive phase 2/3 clinical trials had been started in India. On Dec. 5, Russia began rolling out the vaccine in Moscow for the most exposed groups.

Johnson & Johnson

One of the world’s largest healthcare multinationals, Johnson & Johnson’s Janssen Pharmaceuticals division is under the process of developing a vaccine called JNJ-78436735. It is an adenovector vaccine created from the virus known as Adenovirus 26 – a method that was first used a decade ago by Beth Israel Deaconess Medical Center in Boston, Massachusetts, U.S. The same process was used by Johnson & Johnson to develop the Ebola vaccine and vaccine candidates for Zika and HIV. The company aims to produce a billion doses in 2021.

The Phase 1/2 trials were launched in July. According to a study published in Nature journal, tests on rhesus macaques showed that the vaccine’s single dose “induced robust neutralizing antibody responses and provided complete or near-complete protection in bronchoalveolar lavage and nasal swabs following SARS-CoV-2 challenge.” Phase 3 trials were launched in September with up to 60,000 adults as participants from around the world. The U.S. government had pumped in March for the production of the vaccine. In August, the government said that it would pay $1 billion for 100 million doses if the vaccine is approved.

The company announced on Oct. 12 that the trial was paused to investigate an adverse reaction in a volunteer.

CanSino Biologics

CanSino Biologics is a Chinese biopharmaceutical company which, too, used a weakened version of the adenovirus to develop what is called Ad5-nCoV. According to The Lancet journal, the Phase 1 trials showed a “humoral and immunogenic response to the vaccine.” The Phase 2 trials, reported The Lancet, found that vaccine produces “significant immune responses in the majority of recipients after a single immunisation” and “no serious adverse reactions were documented.”

The vaccine is in development in partnership with Institute of Biology of China’s Academy of Military Medical Sciences. On June 25, the Chinese government gave the go-ahead for the use of the vaccine for soldiers as a “specially needed drug” for one year. It was not clear if the vaccination had been made mandatory. The vaccine entered Phase 3 trials in August in several countries, including Saudi Arabia, Pakistan and Russia. The company’s co-founder announced on Nov. 21 that late-stage human trials will be launched in Argentina and Chile.

Novavax

The company based in Gaithersburg, Maryland, U.S., had in March announced that it had produced a stable, prefusion protein nanoparticle vaccine candidate. The protein-based vaccine named NVX-CoV2373 basically uses the coronavirus’ spike proteins along with a nanoparticle, which triggers an immune response when injected with the Matrix-M adjuvant. Using the same mechanism, the company had developed a vaccine for flu whose Phase 3 trials had ended in March. The vaccine has to be administered in two doses, spaced by 21 days.

Phase 1 trial was launched in May, whose results, released in September in the New England Journal of Medicine, revealed that it was safe, stimulated T cells and “elicited immune responses that exceeded levels in COVID-19 convalescent serum.” The U.S. government gave $1.6 billion for the vaccine’s clinical trials and manufacturing in July. The next month, Novavax launced Phase 2 trials in South Africa on 2,900 people to study its efficacy as well as safety. Phase 3 trials were launched in September for 10,000 volunteers in the U.K. Plans are on to launch a larger Phase 3 trial in the U.S. in October. The company aims to supply 100 million doses in the U.S. by the first quarter of 2021 if the vaccine succeeds. It also has an agreement with Serum Institute of India for production of around two billion doses a year.

Murdoch Children’s Research Institute

Murdoch Children’s Research Institute (MCRI) is the largest health research institute in Australia. In April, the institute began trials to see if the Bacillus Calmette-Guérin (BCG) vaccine can successfully fight off coronavirus. BCG vaccine is used to prevent tuberculosis. Evidence suggests that the vaccine might help boost the immune system against other diseases, though the World Health Organization (WHO) does not hold the view that it may help in combating coronavirus. There are conflicting studies about the impact of coronavirus on those already vaccinated with BCG.

The Phase 3 controlled trial, called BRACE, started with an objective to recruit around 4,000 healthcare workers in Australia. The project is a collaboration between MCRI, Melbourne University and the Royal Children’s Hospital. It was subsequently expanded to include 10,000 healthcare workers from two more countries – Spain and Netherlands – following a grant from the Bill & Melinda Gates Foundation.

24/24 SLIDES

The World Health Organization does not recommend countries issuing “immunity passports” for those who have recovered from COVID-19, but is looking at prospects of deploying e-vaccination certificates and is working on a pilot project for such a scheme with Estonia.

Earlier on Monday, Russia reported 23,351 new coronavirus cases over the previous 24 hours, including 3,591 in Moscow, taking the national tally to 3,260,138.

Authorities said 482 people had died, taking Russia’s official death toll to 58,988.

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