Most of Humankind is hoping to be relieved from the terrible Coronavirus pandemic by the arrival of one (and preferably two) vaccines for the SARS-CoV-2 virus that has spawned it. However, the recent reports that there might be political pressures of all stripes to accelerate its arrival, maybe sidestepping all the traditional scientific procedures to certify it, as not only safe but also effective, has frayed the nerves of the concerned public opinion across the globe. Therefore if new and reliable data starts to appear about the more-advanced vaccine candidates, the scientific certification and public support needed for their regulatory approval will solidify.

In a previous article, we have already discussed the innovative design of the Novavax vaccine. C.Keech et al., from Novavax, have submitted a peer-reviewed article about the Phase 1 and 2 trials of their Recombinant Spike Protein Nanoparticle vaccine. They had set up “a randomized, placebo-controlled, phase 1-2 trial to evaluate the safety and immunogenicity of the rSARS-CoV-2 vaccine (in 5-ug and 25-ug doses, with or without Matrix-M1 adjuvant, and with observers unaware of trial-group assignments) in 131 healthy adults)” The participants were divided thus:

  1. a) Eighty-three (83) participants were given the vaccine plus the adjuvant.
  2. b) Twenty-five (25) participants were given the vaccine without the adjuvant.
  3. c) Twenty-three (23) participants received a placebo.

The researchers reported the initial results of the Phase 1, which was started in May. The Novavax vaccine is a recombinant nanoparticle vaccine designed with the full-length wild-type SARS-C0V-2 spike glycoprotein previously biologically primed in the baculovirus Spodoptera frugiperda insect cell-expression system. The rSARS-CoV-2 is resistant to the degradation to proteolytic cleavage, successfully binds with the hACEe receptor and is sufficiently stable at different temperatures. The company also manufactured the Matrix-m1, a saponin-based adjuvant, which was mixed with rSARS-CoV-2 right before the application to individuals. There were two injections in the deltoid muscle (both for the vaccine and the placebo) separated by 21 days.

First of all we must say that there were no serious adverse events for any  participants (thank you God Almighty for illuminating those brave scientists’ minds and hands) The addition of the adjuvant boosted the immunogenicity response by inducing a T helper 1 (Th1) response, which bode very well for the possibility of a much longer immunological defense for vaccinated individuals. Every participant was duly observed for half an hour after each injection and were given a dairy to carry home. “Predefined local (injection site) reactogenicity included pain, tenderness, erythema, and swelling; systemic reactogenicity included fever, nausea or vomiting, headache, fatigue, malaise, myalgia, and arthralgia.” The reactogenicity was also mild after the second vaccination and there was not a safety pause for any participating individual. The laboratory abnormalities of grade 2 or higher occurred in 13 participants (10% of the group) but were not associated with any grave clinical presentation. Six individuals (5 women and 1 man) had transitory lowering of the Hemoglobin values, with no evidence of microcytic anemia or hemolysis (destruction of red blood cells)

The evidence of an immunological defense set up by the bodies of participants was assessed by measuring the anti-spike IgG ELISA unit responses to rSARS-CoV-2 protein antigens, measured at days 0, 7,21,28 and 35. Those results were compared with a control panel of 32 (IgG) and 29 (MN) convalescent serum harvested form patients with PCR-confirmed infection that eventually successfully recovered. “ELISA anti-spike IgG geometric main ELISA units (GMEUs) ranged from 106 to 116 at day 0. By day 21, responses had occurred for all adjuvanted regimens…and geometric mean fold rises (GMFRs) exceeded those induced without adjuvant by a factor of at least 10. Within 7 days after the second vaccination with adjuvant…had further increased by a factor of 8…over responses seen with the first vaccination, and within 14 days (day 35) responses had more than doubled yet again, achieving GMFRs that were approximately 100 times greater than those observed with rSARS-CoV-2 alone.”

These initial results are certainly encouraging for those of us anxiously waiting for the vaccine.

Stay distant. Stay safe. Stay beautiful.

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