Source: Vaccine News  Feb 01, 2021  2 years ago
Vaccine News: Johnson & Johnson COVID-19 Vaccine Might Be The Best Bet Compared To All Other COVID-19 Vaccines So Far
Vaccine News: Johnson & Johnson COVID-19 Vaccine Might Be The Best Bet Compared To All Other COVID-19 Vaccines So Far
Source: Vaccine News  Feb 01, 2021  2 years ago
Vaccine News: We at Thailand medical News are typically skeptical about all the various COVID-19 vaccines being promoted currently due to the fact that many were developed in such a rush, bypassing standard testing and procedures, lack of transparency  coupled with the fact that the past track record of coronavirus vaccines have not been very successful, often causing more problems for the tested models or patients including ADE or Antibody Dependent Enhancement and also ‘negative immune priming’.

However after carefully looking at whatever published data and also information procured from other sources, our recommendations are that if anybody really had no choice and had to go for a COVID-19 vaccine at the moment, then the best choices in order would be:
-Janssen or Johnson & Johnson's Ad26.COV2.S Vaccine (USA/Belgium)
-Sinopharm’s BBIBP-CorV Vaccine -China
-Bharat Biotech BBV152Vaccine –India
The latter two are based on past tested technologies of using inactivated whole virions and the adjuvants used have tested safe profiles. Though their efficacy results showed a lower percentage, at least the Chinese and Indian manufacturers were not over exaggerating like some of the other vaccine manufacturers plus these Chinese and Indian manufacturers have been in the vaccines industry for a long time with a good track record.(We will be covering details of these two vaccines in another coming article.)
Coming back to the Johnson & Johnson's Ad26.COV2.S Vaccine, initial Interim results of a Phase 1–2a trial of Ad26.COV2.S Covid-19 vaccine published in the New England Journal Of Medicine in January 2021 showed positive results.
Furthermore the initial results from Janssen (Johnson & Johnson's) global Phase III ENSEMBLE clinical trial released a few days ago showed that its single-shot vaccine is 66% effective overall in preventing moderate-to-severe COVID-19, 28 days after vaccination.
Although these results do not appear to be overly impressive, dwarfed by Pfizer/BioNTech’s 90% and Moderna’s  94.5%, this isn’t the whole story.
ong>As new strains began to emerge in the late days of 2020, the challenge for the next vaccine manufacturers in line became more difficult, and the 66% J&J announced included participants infected with the emerging South African B.1.351 viral variant!
Also most significantly, the Janssen vaccine was 85% effective in preventing severe disease after 28 days across all geographical regions, and efficacy increased over time, with zero cases reported in vaccinated participants after the 49th day. It also demonstrated complete protection against COVID-19 related hospitalization and death. There were no reported cases requiring hospitalization, ICU admission, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) 28 days post-vaccination.  
Janssen Research & Development Global Head, Dr Mathai Mammen, M.D., Ph.D told Thailand Medical News, “Changing the trajectory of the pandemic will require mass vaccination to create herd immunity, and a single-dose regimen with fast onset of protection and ease of delivery and storage provides a potential solution to reaching as many people as possible. The ability to avoid hospitalizations and deaths would change the game in combating the pandemic.” 
On the whole, against moderate-severe COVID-19 infection, the vaccine was 72% effective 28 days after vaccination in the U.S., 66% in hard-hit Latin America, and bottomed out at 57% in South Africa.
It must be noted that this last number, combined with the 49% overall efficacy announced a few days back by Novavax, sets off alarm bells that the variants stemming from B.1.351 may have wandered away from the protection of current COVID-19 vaccine science. 
However Janssen’s single-shot vaccine could go a long way in democratizing the global battle against the pandemic, given its clear logistical benefits, particularly for less-developed infrastructures. The vaccine is compatible with standard distribution channels and is estimated to remain stable for two years at -20°C (-4°F).
Johnson & Johnson Vice Chairman of the Executive Committee and Chief Scientific Officer, Paul Stoffels, M.D added, “These topline results with a single-shot COVID-19 vaccine candidate represent a promising moment. The potential to significantly reduce the burden of severe disease, by providing an effective and well-tolerated vaccine with just one immunization, is a critical component of the global public health response." 
He said, "A one-shot vaccine is considered by the World Health Organization to be the best option in pandemic settings, enhancing access, distribution, and compliance. Eighty-five percent efficacy in preventing severe COVID-19 disease and prevention of COVID-19-related medical interventions will potentially protect hundreds of millions of people from serious and fatal outcomes of COVID-19. It also offers the hope of helping ease the huge burden placed on healthcare systems and communities."
Once approved, the Janssen vaccine’s 72% overall effectiveness in the U.S., and 85% against severe disease, would add another vaccine to the country’s arsenal and help to reduce the strain on the already overwhelmed healthcare system. According to data from the COVID Tracking Project, while overall U.S. cases have declined during the past week, the 7-day average for deaths increased and 108, 957 thousand remained hospitalized as of Tuesday. 
 J&J plans to file for U.S. Emergency Authorization Use (EUA) early next month and expects to begin shipments immediately.
Numerous experts Have voiced positive sentiments over the Johnson and Johnson vaccine’s phase 3 ENSEMBLE Trial results:
Co-lead COVID-19 team at the African Academy of Sciences, and Professor of Tropical Medicine University of Oxford, Prof Kevin Marsh commented,
“The Phase 3 trial results of the Johnson & Johnson Single-Shot Janssen COVID-19 Vaccine Candidate announced today are extremely encouraging. Particular strengths of the study are its size (over 40,000 people), the spread of participants over 8 countries and three continents, and a wide range of ages.  It is possible that some people will look at the overall reported efficacy of 66% in preventing moderate to severe COVID-19 and focus on comparisons with potentially higher ‘top line’ efficacy reported for some other vaccines.  This would be a mistake.  The real headline result is that a single shot vaccine, capable of easy long term storage and administration provided complete protection against hospitalization and death.  This is important because the immediate requirement of vaccination globally is to limit deaths as quickly as possible.  While potentially important for all regions, these results are especially encouraging for Africa and LMIC’s globally where the combination of single shot, ease of storage and protection against multiple variants is critical.”
Viral immunologist at the University of Birmingham, Dr Zania Stamataki said,
“The study results are exciting and come at a time when there is a desperate need for more vaccines. The single shot regimen allows flexibility but it is too early to assess the duration of protection. Importantly, the vaccine prevented moderate and severe COVID-19 for multiple variants (57% efficacy for the South African variant compared to 72% protection in the US). A valuable addition to our arsenal against COVID-19.”
Associate Professor in Cellular Microbiology at the University of Reading, Dr Simon Clarke added, “The announcement of successful clinical trials for the Johnson & Johnson Covid-19 vaccine means a welcome addition to the repertoire.  Like all the other vaccines currently available, it generates an immune response against the virus spike protein.  A cold-causing virus is used to deliver the gene for the spike to our cells so that they make the protein in the absence of any coronavirus.  It is also stable at refrigerator temperature, making it easier to administer in GP practices that don’t have substantial cold chain facilities.  It should also be portable enough to take into care homes and other places that might be hard to reach. The trial data revealed some interesting findings.  Efficacy was high in the United States, but was lower in South Africa, decreasing by about a fifth.  Biochemical predictions and limited laboratory studies have suggested that South Africa’s dominant variant may be less susceptible to the actions of the current crop of vaccines.  These data provide further evidence that in humans, the South African variant of the coronavirus may have developed partial resistance to vaccination.”
Chair of the Policy and Communications Group, Faculty of Pharmaceutical Medicine, Dr Sheuli Porkess commented, “The Faculty of Pharmaceutical Medicine welcomes the latest data on the vaccine developed by Janssen, part of Johnson & Johnson (J&J). Whilst progress with vaccination in the UK is accelerating, we have also seen that the virus continues to cause serious illness, hospitalizations and deaths, so evidence from more vaccines is very welcome. Whilst the J&J vaccine is not yet approved for use, it will be hopefully be helpful as part of the overall global effort to get as many people vaccinated as fast as possible. The J&J vaccine uses viral vector technology with a human adenovirus, which was used in Janssen’s vaccine against Ebola.  With this type of vaccine, the harmless adenovirus transports the genetic code (DNA) for the spike protein into cells which then produce the spike protein, triggering an immune response. The data comes from the phase 3 ENSEMBLE trial (a single dose placebo controlled double blind randomized study in 43,793 participants), which was conducted in collaboration with the US government and the US National Institute of Allergy and Infectious Diseases (NIAID).  The studies were conducted in USA, Peru, Mexico, Argentina, Brazil, Colombia and South Africa. 34% of participants were over age 60. The vaccine has been developed as a single dose regimen for people aged 18 years and over. The vaccine is estimated to remain stable for two years at -20°C (-4°F), at least three months of which can be at temperatures of 2-8°C (36°F–46°F). We now have three vaccines approved for use in the UK, the Pfizer/BioNTech vaccine, the Oxford/AZ vaccine, and the Moderna’s vaccine.  We look forward to seeing the outcome of regulatory review of the J&J vaccine, with many others still in development. As with all vaccines that are approved by the MHRA, this vaccine would need to demonstrate rigorous safety and quality standards enabling widespread use.  Effectiveness and safety monitoring would be continued following use of the vaccine in practice.”
Senior Research Fellow in Global Health, University of Southampton, Dr Michael Head said, “Just hot on the heels of the Novavax findings we have further news of an effective COVID-19 vaccine.  The overall observed effectiveness was 66% protection against moderate COVID-19 disease and 85% protection against severe disease.  There are again slight differences in the effectiveness against moderate disease between USA (72%) and South Africa (57%).We do need to vaccinate the world, and there’s about 8 billion people out there.  So the chance to have multiple vaccines available is excellent, and a single-dose product of course has advantages in terms of cost and logistics for a large-scale roll-out.  It can also be quickly manufactured at large scale.”
Associate Professor in Biomedical Technology, Reading School of Pharmacy, University of Reading, Dr Alexander Edwards commented, “Today we hear more great news about new COVID-19 vaccines.  The exciting news regarding the Janssen vaccine is that this entire clinical trial assessed a single dose – rather than two doses used for all previous trials reported.  The type of vaccine is similar to the AstraZeneca/Oxford viral vector, so will require similar manufacturing capacity. We need to see more details and eagerly await the detailed trial results.  It’s not possible at this stage to compare the protection provided by different vaccines, each trial has different protocols, and a head-to-head comparison is the only fair way to unpick if one vaccine is better than another.  As we start to build up multiple data sets from many different trials, we can start to understand what types of immune response provide protection, this remains vital to deal rapidly with any further variants. There has been great debate about 1 vs 2 doses and timing of doses for the first few vaccines to be rolled out.  Hopefully, whilst this is a different product, this trial starts to provide evidence that single dose vaccination can be protective.  However, because this is a different vaccine product, which may be more effective in single dose than other products, we certainly can’t conclude that a second dose isn’t needed for other vaccines; people must still make every effort to complete a full course of two doses for those vaccines.  The benefits of single dose become clearer as larger scale vaccination takes place, for example when we are at a stage where we can vaccinate whole populations rather than the current focus on protecting the most vulnerable groups and age ranges, so this product could become very useful.”
Thailand Medical News would like to highlight that Johnson & Johnson's Ad26.COV2.S Vaccine uses a patented AAV or adeno associated virus  vector platform called AdVac® technology and though our concerns about the usage of such vector platforms, , Johnson and Johnson has addressed this issue in its new patented technology.
We at Thailand Medical News are not advocating anything about these COVID-19 vaccines, we are merely suggesting that if an individual has no choice and is forced to have a COVID-19 vaccine, then perhaps the Johnson and Johnson vaccines along with Sinopharm’s and Bharats Biotech’s vaccines would seem to be safer bets. Also at this stage however, we do not recommend anyone above 65 years of age having these vaccines till more data is available to justify its safety for individuals above that age.

However we are wary of the RNA vaccines being used and promoted as its an untested technology coupled with the fact that the manufacturers involved do not have good track record records and there were certain political groups and billionaires with vested interests involved in expediting these vaccines and also heavily promoting them.(We will be covering that also in a coming article.)
For more Vaccine News, keep on logging to Thailand Medical News.


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