CNN has learned that Russia intends to approve the world’s first coronavirus vaccine in less than two weeks, despite concerns about its safety, effectiveness and that the country has cut essential corners in development.
Russian officials tell CNN they are working towards a date of August 10 or earlier for approval of the vaccine, which has been created by the Moscow-based Gamaleya Institute.
“It’s a Sputnik moment,” said Kirill Dmitriev, head of Russia’s sovereign wealth fund, which is financing Russian vaccine research, referring to the successful 1957 launch of the world’s first satellite by the Soviet Union.
“Americans were surprised when they heard Sputnik’s beeping. It’s the same with this vaccine. Russia will have got there first,” he added.
But Russia has released no scientific data on its vaccine testing and CNN is unable to verify its claimed safety or effectiveness. Critics say the country’s push for a vaccine comes amid political pressure from the Kremlin, which is keen to portray Russia as a global scientific force. There are also wide concerns human testing of the vaccine is incomplete.
Russian officials say the drug is being fast-tracked through registration because of the global pandemic and Russia’s own severe coronavirus problem. Russia now has more than 800,000 confirmed cases.
“Our scientists focused not on being the first but on protecting people,” said Dmitriev, whose government fund is helping finance Russia’s vaccine program.
“Russia marshaled its leadership position in vaccine development and its proven Ebola and MERS vaccine platform to bring the first safe and efficient solution to the world’s biggest problem,” he told CNN previously.
The World Health Organization says there is no approved vaccine for MERS.
29 July 2020, CNN
Dear Muhammed Ashraful Alam , Russia cannot compete with the U.S., Europe and China. Science and technology are ruined there. The only thing that they can make well - propaganda. But the regime is very aggressive and dreams about world leadership, thus I won't be surprised if they use some untested substance to "vaccinate" millions of people. Not to fight the virus (who cares?!), just to make a great look...
The scientific data has not released and human testing of the vaccine is incomplete, actually human testing is a big factor, here, we know it is a time being task. So, until the final approval of the vaccine, waiting is the reality.
Difficult to prove it effect on human, with, without adequate testing.....
Think so dear Bhupendra Desai and yes, we need it urgently but we should be more aware about its effectiveness too.
Vaccine may not be ready until mid-2021, German minister says: The country's minister for research Anja Karliczek issued the warning as she unveiled fresh funding for labs working on a vaccine.
While vaccine makers hope to speed through testing in record time, assessment of safety is also a critical part of these clinical trials.
several countries are working on covid vaccine development now; overall about 200 candidates in the US alone, several in Russia and dozens in other countries world wide. Everyone is trying to rush it- as there is a huge need and a lot of pressure. But realistically- based on interviews with Merck and other leads - innovative vaccine development typically takes 3-5 years, or longer. Launching something end of this year will be pretty much impossible (addressing safety and also efficiency), and scaling up - to distribute world wide and inject 7+ billion people- is another big challenge
Think so sir Alexander Sasha Vlassov and two important issues have been discussed: one is vaccine development and the another one is the availability of vaccine for all in this unequal world.
WHO urges caution over Russia vaccine
4 August, BBC
The World Health Organization has urged Russia to follow international guidelines for producing a vaccine against Covid-19 after the country said it would begin vaccinations in October.
"Sometimes individual researchers claim they have found something, which is of course, as such, great news," WHO spokesman Christian Lindmeier told reporters on Tuesday.
"But between finding or having a clue of maybe having a vaccine that works, and having gone through all the stages, is a big difference."
Last week, the Russian government announced it was preparing to begin mass vaccinations.
However, the Russian vaccine is not among the WHO's list of six vaccines that have reached phase three clinical trials, which involve more widespread testing in humans.
Why do you think so dear Denis Korneev ? USA, Russia, China, UK, Germany, India etc. can do it if they want and the question is make it more rational and make it more clear to all. We should not hide anything related to development of vaccine and WHO urges it several times to make it for all.
Muhammed Ashraful Alam if it's reality, I'm wondering if the vaccine will be available only in Russia?
That is my question too, sir Frank T. Edelmann and if we are divided even in vaccine development or distribution then where is equity or globalization?
Muhammed Ashraful Alam you are right. My fear is that, no matter where the vaccine against the coronavirus is first marketed, there will be a "vaccine nationalism".
Dear Muhammed Ashraful Alam , Russia cannot compete with the U.S., Europe and China. Science and technology are ruined there. The only thing that they can make well - propaganda. But the regime is very aggressive and dreams about world leadership, thus I won't be surprised if they use some untested substance to "vaccinate" millions of people. Not to fight the virus (who cares?!), just to make a great look...
Thanks for your kind sharing again dear Denis Korneev and we need to be more clear and united in vaccine development and distribution.
It is a race for the vaccine against the Covid-19 launched across the planet. Currently, 26 vaccine candidates are in the clinical trial stage, that is, tested in humans, and 139 in the pre-clinical evaluation stage, according to data from the World Health Organization ( WHO). No one can answer this question, only the future that can answer.
The russia has the same chances as the others countries to find the vaccine.
I do agree dear Ouaïl Ouchetto and it's normal in this competitive world.
Russia is not alone in the race for a covid-19 vaccine. Other companies are already in the stage 3 of testing with humans. They are: Oxford University-Astra-Zeneca; Wuhan Institute of Biological Products Sinopharm; Beijing Institute of Biological Products, Sinopharm; Sinovac Biotech, Instituto Butantan; Moderna; (In the stage 3 of testing 1000 volunteers are participating.
Vaccine development is urgent and it is good to try for it but the problem is WHO does not know about it and Russia does it silently without sharing anything about it. That is problem dear Jean-Pierre Jost and we should be united and more clear in this crisis.
WHO urges caution over Russia vaccine
4 August, BBC
Thanks for your opinion dear Hussein J. Hussein and actually it's most welcome for developing vaccine in any situation but the concern is avoiding WHO or global sharing. We should be more clear at least sharing in this crisis and no need to blame each other.
Today Russia approved its vaccine without an efficacy trial.
Russian vaccine is Adenoviral vector based (non-replicating). Most people have immune response to Adenoviruses, so such vaccines have not worked in the past. Then there is a problem with the booster dose as you get immune response to Adenovirus after first dose. The Russians have designed 2 vaccines – one for first injection (Adeno 26) and 2nd for the 2nd injection (Adeno5). I found this info on clinicatrials.gov
https://clinicaltrials.gov/ct2/show/NCT04436471?term=vaccine&cond=covid-19&draw=4
Component 1, rAd26 Component, 1 vaccination
Component 1 consists of a recombinant adenovirus vector based on the human adenovirus type 26, containing the SARS-CoV-2 S protein gene
Component 2, rAd5 Component, 1 vaccination
Component 2 consists of a vector based on the human adenovirus type 5, containing the SARS-CoV-2 S protein gene.
Prime-Boost Immunization
Day 1 rAd26 Component Day 21 rAd5 Component
I am not sure if Russians did Human Challenge studies. A few days back, there was a news that they released the participants of the trial from a hospital. For regular vaccine trials you don’t keep the participants in a hospital, only for human challenge studies.
I have concerns about the Adenovirus vectored vaccines. You may find more information at a Webinar I gave ob June 30, 2020. Please follow the link for more information.
https://www.linkedin.com/in/rajesh-k-gupta-73a83911/detail/recent-activity/shares/
Thanks for sharing dear Rajesh K Gupta and It's informative too.
Hussein J. Hussein it's not more than a claim. Personally I would never take this Russian fake vaccine because it has not been sufficiently tested (phase III of the testing was skipped). I think this stuff presents a real danger! Fortunately many other vaccines are currently being developed.
The important things are safety and effectiveness. Thanks for sharing here dear Frank T. Edelmann
Frank T. Edelmann , Russia started the development of this vaccine at the same time as other countries.
It is true that this Russian vaccine has not been sufficiently tested. So if another country X produces a vaccine Y in this month or even next month. It will not also have been sufficiently tested. Are you going to have the same opinion of vaccine Y.
Thanks for asking, Sir,
I think that politics should not be introduced into the vaccine.
Russia found the vaccine and pledged to share consultations with the World Health Organization ... Congratulations to Russia..
Until and unless if the vaccine does not come into the market till then all these things are rumors or unbelievable.
Thanks for sharing dear Ouaïl Ouchetto, Michael Issigonis, Tanvir Singh and it's not a matter of USA, Russia or China. We need a safe and effective vaccine and we need to see equal distribution in this global crisis. You need to break the wall of divisions at least in this pandemic crisis.
We need an effective vaccine only and yes, no more politics here dear Mohamed Farid Benlamnouar
Doubts are raised about the safety and efficacy of vaccine even by WHO and many other experts from across the world. Clinical trials are said to be conducted not in full and hastily although the vaccine is made available for masses.
Yes, no chance to compromise with effectiveness and safety of vaccines, dear Shrikaant Kulkarni and no need to start a political race too.
Muhammed Ashraful Alam unfortunately the political race has already been opened. I'm sure that India will announce their first COVOD-19 vaccine on August 15th, which is their Independence Day.
I have already spoken and answered this question. Of course,
if it is true, then it only pleases. But as noted, there are
no promising publications. Everything is done at a fast pace.
And this is alarming. Vaccines are not made so quickly,
no way. This is the life of people, it can cause side effects,
and they can appear and do not appear immediately. I do not
really trust such statements.
Muhammed Ashraful Alam according to the link cited below, "more than 200 COVID-19 vaccines are in development worldwide and several are already in phase III trials".
https://www.nature.com/articles/d41586-020-02386-2
India, UK, USA-all are trying. If it's safe and effective then we should be happy, dear Frank T. Edelmann and in case of so many vaccines we can get chance of dealing with the price even in vaccine nationalism. There should be no monopoly business with COVID-19 vaccine.
Did you know that? Even if a good vaccine becomes available, many people don't want to take it!
https://geneticliteracyproject.org/2020/08/12/35-of-americans-say-they-will-not-get-a-fda-approved-covid-vaccine-even-if-free/?fbclid=IwAR0Rw3Ci-IlrHS0D2iimS0ek5b7YKyXvs3RuuxwMpQPD43JM7i4StH3ae2g
Yes, I read that dear Frank T. Edelmann but the world does not mean USA. We saw lots of protest without face mask or no social distancing in so many cases in USA. It's not a good lesson for others. Still they are divided with reopening of schools. They are too much democratic and there might be decision-making problem. The world needs an effective vaccine and it should be accessible to all at any cost otherwise it will be difficult to control. It was in Wuhan, China for more than 2 months then we see the rapid spread of coronavirus across the world. I don't like to give credit to the virus for its vulnerability rather we, the people, made the journey of virus easier for our lack of seriousness and poor health behavior. WHO and national leaders can't avoid their controversial roles in decision-making in different situations. Still we are divided and the virus is spreading smoothly.
Muhammed Ashraful Alam yes, of course you are right in that the world does not mean the USA. However, I'm afraid that this problem could be similar in other countries as well. In our country, Germany;, there is a large portion of the population who refuse being vaccinated.
Yes, I can understand too dear Terekh Alexandr M. and that's why Dr Fauci gave emphasis to believe more on science. In crisis management we can't avoid such conditions. So many factors from individual to global make the pandemic more problematic. We are still trying to solve the crisis even in all odds.
Frank T. Edelmann , I agree with you.
People refuses to be vaccinated.
They have the idea that this race to find a vaccine is to motivate by a financial aspect rather than to cure people.
Muhammed Ashraful Alam I do believe, and hope the vaccines against Covid-19 will come not only from Russia, but also from other countries including Britain, USA and India. Vaccines coming from more countries will be beneficial especially to low income countries as these will be available at relatively cheap and competitive price.
Yes, I think so dear Arbind K. Choudhary and I have already mentioned it in previous comment.
India, China, UK, Germany, USA-all are trying. If it's safe and effective then we should be happy as in case of so many vaccines we can get chance of dealing with the price even in vaccine nationalism. There should be no monopoly business with COVID-19 vaccine.
Russia offers to help US with Covid-19 vaccine; US says no
13 August 2020, CNN
Russian officials in Moscow tell CNN they have offered "unprecedented cooperation" with Operation Warp Speed (OWS), the US multi-agency body set up to accelerate access to effective Covid-19 vaccines and treatments.
But the officials told CNN that the "US is not currently open" to the Russian medical advances.
"There is a general sense of mistrust of Russia on the American side and we believe that technologies -- including vaccine, testing and treatments -- are not being adopted in US because of that mistrust," one senior Russian official told CNN.
White House Press Secretary Kayleigh McEnany said Thursday that President Donald Trump has been briefed on the new Russian vaccine. She said that American vaccines go through "rigorous" Phase 3 testing and high standards.
Other US officials told CNN the Russian vaccine is considered so half-baked in the United States that it hadn't even piqued US interest in a serious way before the rollout. "There's no way in hell the US tries this (Russian vaccine) on monkeys, let alone people," one US government public health official said.
Russia announced on Tuesday that it had developed a vaccine against the coronavirus and President Vladimir Putin said his own daughter had received it. But tests are yet to be completed and some experts are skeptical about the claims.
The race to find an effective vaccine -- more than 20 are in trials around the world -- has global implications, not just for the health of billions of people, but potential billions in revenue for the successful developer and manufacturer.
Russia says US firms interested
Russian officials tell CNN that Russia is open to sharing information about the vaccine and that it would allow US pharmaceutical companies to produce the Russian vaccine on American soil.
CNN previously reported that Russia says some US pharmaceutical companies are interested in learning about the Russian vaccine, although the names of the firms have not been disclosed.
Ouaïl Ouchetto currently the race to find a vaccine against the coronavirus also has a political component. Governments put a lot of pressure on companies who are developing COVID-19 vaccines.
Hermann Gruenwald personally I would refuse to take the Russian vaccine.
India’s COVAXIN is tested safe in first trial, announced today; devloped by the Bharat Biotech and ICMR. Bharat Biotech previously developed many vaccines for mankind and very good track record. If COVAXIN will pass the next succesive trials, this will be a game changer and will be the one of the trusted vaccine. They hope they can start the production within November End.
It's a good news if it's effective one, dear Gourab Das and we need more to break the monopoly business.
At this moment of time it is not important who come up first with the vaccine. Only important is vaccine should be effective , beneficial and have capabilities to cure the problem adequately and quickly.
Think so dear Tanvir Singh and safety and effectiveness are more important.
14 August, CNN
Vaccine trial investigator says results unlikely to come before end of the year
Dr. Evan Anderson, principal investigator for the Moderna coronavirus vaccine clinical trial at Emory University, says the trial won’t yield results until after Election Day.
“At this point, it looks very unlikely that we would see any results before late November or December, at best, in my opinion. But it does depend how much Covid-19 is circulating in the community at the time that the study is ongoing,” Anderson said in an interview with CNN's Kate Bolduan.
Moderna is the first company to begin its phase three clinical trials of a coronavirus vaccine in the US.
Enrollment is increasing rapidly, according to Anderson, and he predicts that full enrollment won’t happen until September.
Anderson said there would need to be studies to look at dosing and responses of children to the vaccine to determine if it is safe for them, and cautions that could “take a while.”
“I think it would be good to be able to start those studies soon so that we might be able to help protect children from Covid-19, as it is quite clear that they are infected with some frequency and do suffer life-threatening and even fatal events related to Covid-19 and the inflammatory syndrome that occurs afterwards,” he said.
14 August, CNN
Early results suggest Chinese vaccine is safe and induces immune response, but more research is needed
Interim results of phase one and two trials published in the Journal of the American Medical Association suggest a coronavirus vaccine developed by the Chinese pharmaceutical company Sinopharm is safe and induces an immune response.
However, researchers said more study is needed to know whether the vaccine protects people against the virus.
Now Russia is not the only country producing vaccine against this virus. Like all other vaccines of first generation they will be tested and based on the results and secondary reactions a second generation, possibly more effective and more safe will be created
Thanks for sharing dear Hermann Gruenwald and Jean-Pierre Jost
Hermann Gruenwald that's a good point. I'm afraid we will soon see a new "vaccine cold war".
Competition is better than conflict dear Frank T. Edelmann and Hermann Gruenwald and if the race is for effective vaccine then it should be welcome. We can get positive results from vaccine race if it's not nationalized.
Yes, dear Abdelrahman Ibrahim , just need a safe and effective vaccine and it should be distributed equally. Vaccine nationalism should be a crime in this global crisis.
No matter it's Russia or USA dear Hermann Gruenwald , even India or China can bring the vaccine. We need a safe and effective vaccine with its equitable distribution.
Yes, safe, effective, durable, and economical vaccine is required which reaches the needy peoples efficiently and quickly.
Muhammed Ashraful Alam
The news says about Russian vaccine but still there are doubts on its safety. What matters us is its safety irrespective of the countries.
It's not for Russia or USA dear Raj Kumar Baral , effectiveness and equity should be ensured to control the global crisis.
Muhammed Ashraful Alam
Read my line " What matters us is its safety irrespective of the countries." Perhaps you got my point.
Ensuring equity in vaccination is another issue dear Raj Kumar Baral and it's badly needed to control the pandemic crisis.
Muhammed Ashraful Alam
You are right. Unless it is distributed with the principle of equity, to curb Corona is very difficult.
I would never trust the Russian vaccine. Perhaps they tested it with Alexey Navalny...
Russian opposition leader Alexey Navalny was poisoned, Berlin hospital says
https://edition.cnn.com/2020/08/24/europe/alexey-navalny-germany-poison-grm-intl/index.html
Several countries are working on different vaccines and any country can claim the effectiveness of its vaccine. These countries must test them on their population and the country which has no more cases and deaths, it is he who has the most effective vaccine.
Ouaïl Ouchetto as of today, more than 170 candidate vaccines are now being tracked by the World Health Organization (WHO).
https://www.theguardian.com/world/ng-interactive/2020/aug/25/covid-vaccine-tracker-when-will-we-have-a-coronavirus-vaccine
Frank T. Edelmann , thank you for the information.
we will see that they will find an effective vaccine.
Competition is always welcome to avoid monopoly business but the conflict should be avoided. No need to see the super power, we want only effective vaccine and want to see its equity dear Frank T. Edelmann Ouaïl Ouchetto .
Dear Muhammed Ashraful Alam
China has reportedly started vaccinating its people:
https://indianexpress.com/article/explained/august-25-coronavirus-vaccine-latest-covid-19-updates-6568655/
This is the latest update.
Regards,
Arbind
I am not wondered dear Arbind K. Choudhary and it's possible in this competitive world. We have seen many irrational decision-makings before in many occasions by super powers and the world was silent in every time. Just need an effective vaccine and want to see its equitable distribution.
25 August, CNN
Fauci warns against early authorization of vaccine: Any effort to authorize and distribute a coronavirus vaccine before it has been proven safe and effective in large trials could damage efforts to develop other vaccines, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said Monday.
Belarus to become first country to receive Russian coronavirus vaccine
25 August, CNN
Belarus will become the first country to receive doses of a potential coronavirus vaccine being developed in Russia as part of a new agreement reached by Presidents Vladimir Putin and Alexander Lukashenko on Monday.
According to the state-owned Belarusian Telegraph Agency (BeITA), the two leaders agreed that Belarusian citizens will participate in the third stage of Russian vaccine trials, on a voluntary basis.
In a press release, the Kremlin added that the telephone call between Putin and Lukashenko focused on “bilateral cooperation” between the two states, as well as the situation in Belarus.
Mass demonstrations over August's disputed presidential election are now entering a third week in Belarus.
“Alexander Lukashenko informed [Putin] about the measures being taken to normalize the situation in the country,” the Kremlin statement added.
Please see this link reporting that "Only 24 percent of Russian doctors would take the vaccine, one survey shows."
https://www.nytimes.com/2020/08/23/world/europe/russia-coronavirus-vaccine.html
High-profile COVID-19 vaccines developed in Russia and China share a potential shortcoming: They are based on a common cold virus that many people have been exposed to, potentially limiting their effectiveness, some experts say.
CanSino Biologics' vaccine, approved for military use in China, is a modified form of adenovirus type 5, or Ad5. The company is in talks to get emergency approval in several countries before completing large-scale trials, the Wall Street Journal reported last week.
A vaccine developed by Moscow's Gamaleya Institute, approved in Russia earlier this month despite limited testing, is based on Ad5 and a second less common adenovirus.
https://www.google.com/amp/s/www.voanews.com/covid-19-pandemic/scientists-see-downsides-top-covid-19-vaccines-russia-china%3famp
Why some Russian teachers are rejecting Covid-19 vaccine
As schools in Russia have reopened, authorities will allow doctors and teachers to be among the first to access the Sputnik V coronavirus vaccine -- before it completes Phase III human trials. While some educators were on board to get vaccinated, others were concerned about the safety of the vaccine. CNN's Matthew Chance reports. https://www.google.com/amp/s/amp.cnn.com/cnn/videos/world/2020/09/02/russia-coronavirus-covid-19-school-reopen-vaccine-chance-pkg-intl-hnk-vpx.cnn
Protest developed in the international scientific community over the announcement of the vaccine registration in Russia, mainly because there has been no publication of results from clinical trials on Gam-COVID-Vac. There exists no evidence for the safety, effective dose, biomarkers of an immune response, or efficacy against COVID-19 infection. https://en.m.wikipedia.org/wiki/Gam-COVID-Vac
See this important link about the Russian coronavirus vaccine:
Russian coronavirus vaccine may be dangerous, German health minister warns
https://www.politico.eu/article/russia-coronavirus-vaccine-dangerous-germany-health-minister-warns/
The vaccine was to be administered to teachers and medics as priority but they have shunned from it owing to credibility issues.
Latest news: Venezuela seeks testers for Russian vaccine
https://www.bbc.com/news/world-latin-america-53972641
One more reason not to take the Russian vaccine:
Aleksei Navalny Was Poisoned With Novichok, Germany Says
https://www.nytimes.com/2020/09/02/world/europe/navalny-poison-novichok.html
3 September, CNN
Pfizer's Covid-19 vaccine trial should have enough data to know if it works by end of October, CEO says
Pfizer Chairman and Chief Executive Officer Dr. Albert Bourla said the ongoing clinical trial for a Covid-19 vaccine has enrolled about 23,000 participants, and some are already getting the second dose of the vaccine.
Pfizer “should be able to have enough events to say, if the product works or not” by the end of October, Bourla said, speaking on Thursday to the International Federation of Pharmaceutical Manufacturers and Associations.
“We have already worked on the rest of the file,” he said, meaning if the vaccine is effective, “we are going to start submitting to the FDA, on a rolling base.”
Bourla said if they are able to determine the vaccine is safe and effective “in the October time frame,” the company could “submit immediately for approval.”
Pfizer is in the “very advanced stage” of the clinical trial, Bourla said, confirming that as of yesterday, 23,000 patients were enrolled into the study. Pfizer is aiming to enroll 30,000 patients in the Phase 3 trial.
A scientific opinion poll of Canadians conducted by Léger found that a majority (68%) would not take the Russian vaccine if offered a free dose, compare to 14% who said they would take it. https://en.m.wikipedia.org/wiki/Gam-COVID-Vac
Vaccine scientists have called the Russian government's approval of Gam-COVID-Vac "dangerous", "reckless", and "foolish". Professor Paul Offit, who is the director of the Vaccine Education Center at Children’s Hospital of Philadelphia, stated that the announcement was a "political stunt", and that the untested vaccine could be very harmful.[6] A spokesperson for the Association of Clinical Research Organizations in Russia said, "I feel only shame for our country. Accelerated registration will no longer make Russia a leader in this race, it will only expose end users of the vaccine, citizens of the country of the Russian Federation, to unnecessary danger."
https://en.m.wikipedia.org/wiki/Gam-COVID-Vac
Venezuela seeks 500 "volunteers" to test the Russian COVID-19 vaccine:
https://www.bbc.com/news/world-latin-america-53972641?intlink_from_url=https://www.bbc.com/news/explainers&link_location=live-reporting-story
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