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Brazil health regulator rejects Russia's Sputnik vaccine - presence of the adenovirus that could reproduce

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  • Brazil health regulator rejects Russia's Sputnik vaccine - presence of the adenovirus that could reproduce

    Published Monday, April 26, 2021 10:34PM EDT

    Ricardo Brito, Reuters Staff

    BRASILIA -- The Brazilian health regulator Anvisa on Monday rejected importing the Russian-made Sputnik V COVID-19 vaccine requested by state governors battling a deadly second wave of the virus that is battering Latin America's largest nation.

    Anvisa's five-strong board voted unanimously not to approve the Russian vaccine after technical staff had highlighted "inherent risks" and "serious" defects, citing a lack of information guaranteeing its safety, quality and effectiveness.

    ... A crucial issue was the presence in the vaccine of the adenovirus that could reproduce, a "serious" defect, according to Anvisa's medicines and biological products manager Gustavo Mendes. ...

  • #2
    Thank you, Mary. There's an aspect of this vector I preferred over at least one of the other vector vaccines. We'll see if this is really reproducing.

    Brazil rejects Sputnik V vaccine, says it?s tainted with replicating cold virus
    Adenovirus-vector vaccines are supposed to be engineered so they can?t replicate.
    Beth Mole - Apr 29, 2021 6:18 pm UTC
    Moreover, quality-control issues weren?t the end of Anvisa?s concerns. In an overall evaluation of the Russian vaccine, Brazil?s regulators found its safety and efficacy were based on insufficient, limited, and sometimes faulty data and analyses. ?Flaws... were identified in all stages of clinical studies,? Anvisa said. The agency also reported that its inspectors who traveled to Russia to assess the vaccine?s production were barred from vaccine facilities at Gamaleya Institute, which developed Sputnik V...
    Russia cries ?sabotage? after Slovakia questions quality of Sputnik vaccine
    Russia now says it wants its vaccine back from Slovakia.
    Beth Mole - Apr 9, 2021 9:30 pm UTC

    Ask Congress to Investigate COVID Origins and Government Response to Pandemic H.R. 834

    i love myself. the quietest. simplest. most powerful. revolution ever. ---- nayyirah waheed

    (My posts are not intended as advice or professional assessments of any kind.)
    Never forget Excalibur.


    • #3
      This is something that I hope will be examined closely (for all the live attenuated vaccines) and the data made public, so it can be studied carefully. Does anyone know how many doses of Sputnik have already been given globally? I would have thought that if there was a problem, it could be picked up by sentinel screening.


      • #4
        Number of people vaccinated with the COVID-19 vaccine Sputnik V in Russia as of March 31, 2021, by date of report (in millions)

        Published by Statista Research Department, Apr 29, 2021

        Approximately 3.8 million Russians received both doses of Sputnik V, a vaccine against the coronavirus (COVID-19) developed by the Gamaleya Research Center as of March 31, 2021.
        Sputnik V doses bought from Russia 2021, by country

        Published by Statista Research Department, Apr 26, 2021

        Russia sold 100 million doses of the coronavirus (COVID-19) vaccine Sputnik V to India, which was also among the countries that produced it on its territory. In total, four Indian companies planned to produce 852 million doses of Sputnik V in 2021. Furthermore, Mexico was to import 7.4 million doses between February and April 2021, with more doses to be delivered in May. Sputnik V was authorized in over 60 countries worldwide as of April 2021. Russia applied for the vaccine approval in the European Union in January, while several EU countries approved its use earlier, such as Hungary or Slovakia.


        • #5
          Sputnik V COVID-19 vaccine candidate appears safe and effective - The Lancet

          Published:February 02, 2021

          By Ian Jones, Polly Roy

          ... The trial results show a consistent strong protective effect across all participant age groups. Also known as Gam-COVID-Vac, the vaccine uses a heterologous recombinant adenovirus approach using adenovirus 26 (Ad26) and adenovirus 5 (Ad5) as vectors for the expression of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein. The use of two varying serotypes, which are given 21 days apart, is intended to overcome any pre-existing adenovirus immunity in the population.2 Among the major COVID vaccines in development to date, only Gam-COVID-Vac uses this approach; others, such as the Oxford?AstraZeneca vaccine, use the same material for both doses. The earlier vaccine for Ebola virus disease, also developed at Gamaleya National Research Centre for Epidemiology and Microbiology (Moscow, Russia), was similar, with Ad5 and vesicular stomatitis virus as the carrier viruses,3 and the general principle of prime boost with two different vectors has been widely used experimentally.4

          . ... Vaccine efficacy, based on the numbers of confirmed COVID-19 cases from 21 days after the first dose of vaccine, is reported as 91?6% (95% CI 85?6?95?2), and the suggested lessening of disease severity after one dose is particularly encouraging for current dose-sparing strategies.


          • #6
            Sputnik V Vaccine

            Updated May 1, 2021. Last reviewed May 1, 2021

            Authored by Staff
            Fact checked by Robert Carlson, MD + Kelley Lu, PharmD + Holly Lutmer PharmD
            Sputnik V Vaccine Description

            The COVID-19 vaccine Sputnik V (Gam-COVID-Vac) is an adenoviral-based two-part vaccine against the SARS-CoV-2 coronavirus. Sputnik V uses a weakened virus to deliver small parts of a pathogen and stimulate an immune response.

            The Sputnik V (Gam-COVID-Vac) vaccine reduces the time taken for the actual development of immunity to SARS-CoV-2, the virus behind the COVID-19 pandemic. ...



            • #7
              . A crucial issue was the presence in the vaccine of the adenovirus that could reproduce, a "serious" defect, according to Anvisa's medicines and biological products manager Gustavo Mendes. ...

              The ctvnews article does not elaborate on how Anvisa came to this conclusion which seems odd as this is supposed to be a replication incompetent Ad vector. Has anyone seen any evidence that it is not? Millions of doses have now been administered if it was reproducing it should be easy enough to find adenovirus in someone who had been given it.


              • Mary Wilson
                Mary Wilson commented
                Editing a comment
                There is a 2020 trail to follow with may forks in the road.
                ... Combatting malign influences in the Americas: OGA used diplomatic relations in the Americas region to mitigate efforts by states, including Cuba, Venezuela, and Russia, who are working to increase their influence in the region to the detriment of US safety and security. OGA coordinated with other U.S. government agencies to strengthen diplomatic ties and offer technical and humanitarian assistance to dissuade countries in the region from accepting aid from these ill- intentioned states. Examples include using OGA?s Health Attach? office to persuade Brazil to reject the Russian COVID-19 vaccine, and offering CDC technical assistance in lieu of Panama accepting an offer of Cuban doctors. ...

            • #8

              Is Russia?s COVID-19 vaccine safe? Brazil?s veto of Sputnik V sparks lawsuit threat and confusion
              By Sofia Moutinho, Meredith WadmanApr. 30, 2021 , 5:40 PM

              A confusing and unusually nasty fight broke out this week over the safety of a Russian COVID-19 vaccine known as Sputnik V after a Brazilian health agency declined on Monday to authorize its import because of quality and safety concerns. The stakes escalated yesterday when the Twitter account officially associated with the vaccine said ?Sputnik V is undertaking a legal defamation proceeding? against Brazil?s regulators.

              In an online press conference several hours later, the Brazilian Health Regulatory Agency (Anvisa) defended its decision, maintaining that documentation from some of the Russian facilities making Sputnik V shows that one of its two doses contains adenoviruses capable of replication, a potential danger to vaccine recipients. The vaccine uses two different adenoviruses, which cause the common cold, to deliver the gene for the spike protein of SARS-CoV-2, the virus that causes COVD-19. Both are supposed to be stripped of a key gene that allows them to replicate.

              The Monday announcement left many scientists and media outlets believing Anvisa had directly tested Sputnik V for replicating adenoviruses, which would be unusual for a regulatory agency. But Anvisa has since clarified?it had not and was relying on information provided by the Gamaleya National Center of Epidemiology and Microbiology, the Moscow-based developer of the vaccine.

              ?The data we evaluated shows the presence of replicating virus,? Gustavo Mendes, general manager of medicines and biological products at Anvisa, said at the press conference. Anvisa would not accept the vaccine, he said, without further studies to indicate it is safe.

              Gamaleya said in a statement on its website that Anvisa?s allegations ?have no scientific grounds and cannot be treated seriously.? The research institute added that ?no replication-competent adenoviruses (RCA) were ever found in any of the Sputnik V vaccine batches? and said a four-stage purification process prevents contamination.

              The furor comes as Brazil, which has one of the highest burdens of COVID-19 in the world, is desperately trying to expand its vaccination campaign. The country has vaccinated just 14% of its people with a first dose and governors from some states hoped to bolster that effort by grouping together to buy 30 million doses of Sputnik V.

              The spat has bewildered and divided outsider observers, in Brazil and elsewhere. Some scientists have used social media to decry the apparent contamination and some have denounced the aggressive response by Sputnik V?s backers, who were already under fire for releasing little data on the vaccine?s safety record. On Wednesday, an agency of the European Union also issued a report criticizing Russia?s promotional effort for Sputnik V for providing disinformation...


              • #9
                Surely the relevant rule is that "the best is the enemy of the good".
                Brazil needs to have 'all hands on deck', to try to get on top of this. Nobody cares if it is only 70% effective if the only alternative is 0%.


                • #10
                  The science and politics of this dispute are well covered in TWiV 751 by Kathy Spindler - a life long Adenovirus virologist.


                  • #11
                    JJackson - you beat me to it! The TWiV team give a very good and clear explanation of how adenovirus vectored vaccine lines are produced, and the safety measures undertaken during manufacture. The one aspect they didn't cover (or I didn't grasp) is, is there any potential for recombination if someone receives the vaccine whilst harbouring an active (unrelated) adenovirus infection. Has this been tested for (I would imagine it has). I have looked but cant find any studies on this - perhaps you have?


                    • JJackson
                      JJackson commented
                      Editing a comment
                      I have not seen any research into that. However while the Ad genome is large the excised E1a polyprotein code that makes room for the S gene is the only recombination element that would make the virus replication competent again. For the human Ads if it did happen all it would do is give you the Ad you already had or a not very dangerous virus that most people already have immunity to, 80%ish if I recall correctly. I do not know if there is room to package an extended genome including both the E1a and S but even if it occurred it would just be an Ad that gave you some SARS-CoV-2 protection. Such a mutant is unlikely to survive very long against the wild type.

                    • Vibrant62
                      Vibrant62 commented
                      Editing a comment
                      Thank you.