The odds for vaccine gambling can turn awry

Some things in Life should never be rushed. Real love. Grilled meat. And vaccines.

In a New York Times article, Katherine J. Wu and Katie Thomas said today: “The pharmaceutical company AstraZeneca halted large, late-stage global trials of its coronavirus vaccine on Tuesday because of a serious suspected adverse reaction in a participant, the company said.” This report said that, according to some sources, that adverse reaction in one participant of the United Kingdom’s trial might have been transverse myelitis, a serious neurological inflammatory reaction to viruses.

The Oxford-AstraZeneca product is one of the most advanced vaccine candidates for the SARS-CoV-2 infection, with almost 30,000 participants in Phase 3 clinical trials around the globe. In a previous article, we discussed the encouraging early results of the Phase 1-2 clinical trials of this vaccine, which uses a viral vector to insert the SARS-CoV-2 genetic material into the human cells to provoke an inflammatory response. After assessing its efficacy, it is now being tested for its safety for humans, with extended Phase2/3 trials conducted in the United Kingdom and the Republic of India plus additional Phase 3 trials in Brazil, South Africa and 60 US testing sites.

The Oxford-AstraZeneca administrators did exactly what they were trained to do: once a major clinical complication arises, the whole process must be halted and the case (or cases) must be thoroughly studied by an institutional review board. That clinical complication could have been just a coincidence, but the possibility of a harmful side-effect must be carefully, patiently studied and vetted out. Moreover, large segments of the public in modern nations are already skeptical of vaccines; the emergence of a grave complication, like it happened with an early Polio vaccine in the 1950s, could drastically undermine the trust in this candidate, and others as well.

Aware of the above mentioned profound public suspicion about the safety of any vaccine candidates, nine pharmaceutical companies that are developing them recently signed a formal pledge not to seek any regulatory approval before all the necessary clinical trials have been completed and the data duly examined by them.

This is a welcome backstop to the various political pressures exerted, openly and surreptitiously, on pharmaceutical companies to rush a candidate to market to pander to the scared electorate. We should only pay heed to the “scientific date” for the vaccine’s arrival and not it’s “political one.”Governments that advanced many millions of dollars to speed the development and production of a good vaccine, must realize that they were in fact using “our money” for it.

Crossing fingers, they cannot cavalierly gamble our Health at the roulette table of Blind Hope.

Stay distant. Stay safe. Stay beautiful.

What do you think? Please tell us.

Don’t leave me alone.

Good news about the Novavax vaccine for the SARS-CoV-2 virus

In the mad dash of several pharmaceutical and biotechnology companies to create and test a good vaccine for the SARS-CoV-2 there might a “dark horse” in the crowded race. The company Novavax, that had already received a 1.6 Billion U$ grant from the American government to develop a coronavirus vaccine, have announced good results on August 4. Carl Zimmer and Katie Thomas report in a NY Times article that: “In one study, 56 volunteers produced a high level of antibodies against the virus without any dangerous side effects. In the other, researchers found that the vaccine strongly protected monkeys from coronavirus infections.” These results are being submitted in article proposals to peer-reviewed publications at the present time.

The 33-year company—that never made a commercially viable vaccine so far—used two techniques that are different form the ones we have already discussed. They are:

  1. They use a coronavirus protein that can elicit an immune response in humans.
  2. They use moth cells as more fast factories for a virus protein dubbed as spike.

In order to potentiate the effectiveness of the “spike” they added an adjuvant to the mix; data on mice studies had already established the value of using this adjuvant. They gave different combinations of the spike and the adjuvant to monkeys, who eventually developed good immunogenicity against the coronavirus, even erasing any traces of the virus in the respiratory or ventilatory systems in some of them. In  a Phase 1 clinical trial with 134 volunteers done last May, there were no side effects. After completing that initial trial, the researchers took serum from the vaccinated participants and mixed it with coronavirus and cells. They found a markedly protective effect in the serum that blocked the virus from infecting other virgin cells. They claimed that their vaccine finally produced more antibodies in the participants than in convalescent patients form a Covid-19 infection.

John P. Moore and P.J. Klassse reviewed in an article the prospective SARS-CoV-2 vaccine candidates and concluded that: “By far the most immunogenic vaccine candidates for antibody responses are recombinant proteins, which are not included in the ‘Warp Speed’ immunogens.” In the NY Times article, Dr, Moore was quoted as saying: “the strong response to the vaccine does not surprise me in the slightest.” The protein-based vaccines have a much longer track record of effectiveness than the novel viral genes-based vaccines, being licensed for Hepatitis B and Shingles. Three other protein based-vaccines—from Clover pharmaceuticals, the University of Queensland and Vaxine—are in Phase 1 trials. The US administration has granted 2.2 billion U$ to a joint project by the Sanofi and GlaxoSmithKline companies.

Stay distant. Stay safe. Stay beautiful.

What do you think? Please tell us.

Don’t leave me alone.