The Vaccine — AstraZeneca, BARDA, and the Lancet Report on work from China

A series of reports from the Executive Intelligence Review:

Operation Warp Speed Accelerates Work on COVID-19 Vaccine

May 22 (EIRNS)—According to a Thursday press release by the U.S. Department of Health and Human Services, the U.S. Biomedical Advanced Research and Development Authority (BARDA) has partnered with UK pharmaceutical firm AstraZeneca for the production of 300,000,000 doses of its coronavirus vaccine AZD1222, with the first deliveries to occur in September.

BARDA will provide up to $1.2 billion in support of clinical studies, vaccine manufacture, and other development activities. Phase 3 clinical studies of the vaccine will begin this summer in the U.S., with the recruitment of approximately 30,000 healthy volunteers. A Phase 1/2 study began in April in the UK.

Several aspects are unclear at the time of writing: Will the $1.2 billion include the doses, or will they be purchased separately? Will AstraZeneca attempt to strictly enforce its patents, or will this vaccine, tested and manufactured with government support, be a public good? [JAR]

Updates — What’s Up with this plan? Report from Britain —

Exclusive: Oxford University Covid-19 vaccine trial has 50 per cent chance of ‘no result’

Exclusive: Project leader Prof Adrian Hill warns against ‘over-promising’, as vaccine success is far from guaranteed

Coronavirus researchers may have to ‘chase’ infections to do vaccine tests

Oxford scientists working on a coronavirus vaccine say there is now only a 50% chance of success because the number of UK cases is falling too quickly

Reports on First Human Trial of COVID-19 Vaccine

May 22 (EIRNS)—On Friday, the Lancet medical journal published the first peer-reviewed study on the use of a potential COVID-19 vaccine in human beings. The study by Zhu, Li, et al., “Safety, tolerability, and immunogenicity of a recombinant adenovrius type-5 vectored COVID-19 vaccine,” was primarily designed to test the safety of a vaccine developed by Beijing Institute of Technology and CanSino Biologics. The vaccine is based on a common virus that has been altered so as to be unable to replicate, but which expresses the spike protein of the coronavirus. It therefore causes the body’s cells to create the spike protein, which the immune system can then find and learn how to defeat.

Blood testing at 14 and 28 days after vaccination revealed that there were significant levels of neutralizing antibodies for live SARS-CoV-2 and that T-cells that responded to the spike protein had developed.

This is good news, particularly since this vaccine approach is quite similar to that taken by the University of Oxford’s ChAdOx1 nCoV-19 vaccine, which was taken up by AstraZeneca as AZD1222 and has now received up to $1.2 billion from the U.S. BARDA for production assistance.

The study author point out that it is too soon to come to any conclusions about which among the several types of vaccine being tested would be most effective, since this is the first peer-reviewed paper and there are no others to compare to yet. [JAR]

Positive News on Coronavirus Immunity and Vaccines

May 22 (EIRNS)—Three recent studies provide good news about the potential for coronavirus vaccines and effective immunity.

While it would be entirely unethical to deliberately infect human beings with a potentially deadly virus, animal studies can provide knowledge from biologically similar animals. Two recent studies by investigators at Harvard Medical School using macaques have shown that these primates develop immunity after infection by SARS-CoV-2 and that experimental vaccines are effective in providing protection against infection. And recent research by the Korean Center for Disease Control (KCDC) shows that the occasional positive PCR tests of recovered people do not indicate that they are infectious.

  • On immunity — Abishek Chandrashekar et al. write about immunity in their Science article “SARS-CoV-2 infection protects against rechallenge in rhesus macaques.” Macaques were exposed to the virus (it was inserted into both their noses and throats), given five weeks to recover (the symptoms were mild), and then reinfected with the virus. When they were exposed a second time, the peak viral load in the lungs was 100,000 times lower than for the first infection, while the peak viral load in nasal swabs was at least 50 times lower. Since some of what was detected on nasal swabs was the original injected virus, another technique was used to measure viral replication in the nasal cavities, which revealed a peak load 60,000 times lower than for the first infection. By the second day, no virus was detected in the lungs of any of the macaques.

For these animals (and potentially for humans), infection appears to prevent becoming diseased again, although there is still some viral replication within the very early period after being exposed a second time, meaning that there may be a possibility for a recovered person to be slightly contagious, although no occurrences of this have been documented.

  • On vaccines — Jingyou Yu (who got his master’s degree at the Wuhan virology lab) et al. report on vaccines in their Science article “DNA vaccine protection against SARS-CoV-2 in rhesus macaques.” The DNA vaccines expressed various forms of the virus’s spike protein. Five weeks after initial vaccination (with two boosters at weeks 3 and 5), the animals showed levels of neutralizing antibodies that were comparable to, although slightly lower than, the levels of neutralizing antibodies in recovered macaques and human beings. After being exposed to the virus, by nose and by throat, the vaccinated animals showed median levels of products of virus replication that were 1200 times lower in the lungs and 500 times lower in the nose. Eight of the 25 vaccinated animals showed no signs of virus replication in the nose or lungs at all after virus exposure.
  • On the issue of positive testing after recovery — The PCR tests that look for the virus’s genetic signature do not actually detect infectious virus, but rather look for the presence of portions of the viral RNA. The presence of virus fragments can therefore lead to a positive PCR result without indicating that the person is actually infectious. No infectious virus has ever been gathered from recovered patients.

To test this in a public health manner, the KCDC traced 790 close contacts of 285 recovered COVID-19 patients who later retested positive. They found zero new cases of infection among those contacts.

These results are promising for the potential of creating an effective vaccine that provides lasting immunity, although since the virus is new, no firm conclusions can be made about how long such immunity would be effective or at what rate it would fade. [JAR]

A Brief Note on the Prophylactic Use of Hydroxychloroquine

May 22 (EIRNS)—President Trump is not the only person to use hydroxychloroquine prophylactically. Trials continue to be underway around the world to understand whether or not it is a useful drug. Retrospective studies (ones that look at patients who have already been treated) typically involve only hospitalized patients, but the benefit from the drug may be greater early in the course of infection — or prophylactically (before being infected at all).

Although Trump’s dosing is unknown, typical doses of hydroxychloroquine (rather than the elevated doses used for several days for hospitalized patients) are well studied and the risks are well understood. Trump can get an EKG every day if he chooses, to be on the look out for any potential heart problems, which would be less likely at the normal, low dose than at the hospital doses.

Although it is not entirely clear whether this drug is useful in treating or preventing the coronavirus, taking it prophylactically, particularly in the context of having constantly available and personalized healthcare, as is of course the case for the U.S. President, is not particularly risky, even if it is not known to be helpful. It certainly is not a silver bullet. [JAR]

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