Yesterday we had some more great news on the vaccine front. Since all the current vaccines work in a similar way because they use the original COVID19 spike protein in one way or the other, the fact that we are seeing efficacy in these new vaccines despite the UK and South Africa variants this strongly suggests the existing vaccines will probably also work on these new more aggressive variants too.

All the following data continues the unbroken record that so far in all the clinical trials no patient when the vaccine has had a chance to work has been hospitalised or died from COVID19 infection.

If these or any future variants ever need their own vaccine a very minor tweak to any of the vaccines will be needed and most regulators agree that as we are talking about very minor changes of a few amino acids in the spike protein a full clinical development program will not be required to approve variant vaccines in the future.

Novavax COVID19 Spike Protein Vaccine

This is correctly described as the “First to Demonstrate Clinical Efficacy Against COVID-19 and Both UK and South Africa Variants“. But the J and J vaccine also released data against both variants a few hours later. Instead of tricking the body to make spike protein this vaccine contains the ready-made spike protein and so is more like a typical vaccine. It is NOT live and so should be safe for immune compromised patients such as those with blood cancer.

89% reduction in risk of infection in the Phase 3 UK trial with over 50% of cases due to the new more easily spread and possibly more aggressive UK variant and the rest the original COVID-19 virus.

The UK study enrolled more than 15,000 adult patients, including 27% over the age of 65.

So far there has been 62 cases of COVID19 more than seven days after the second vaccine dose. 56 in the placebo group versus 6 cases observed in the NVX-CoV2373 group. Vaccine efficacy estimate 89.3% (95% CI: 75.2 – 95.4). Only 1 case was severe and this happened in the placebo group.

The vaccine seems to be roughly equal in efficacy between the two main UK variants (original and new more rapidly spreading version).

A preliminary review of the safety database showed that severe, serious, and medically attended adverse events occurred at low levels and were balanced between vaccine and placebo groups.

South Africa Results:   Approximately 90% of cases caused by South Africa variant. Some efficacy in immune compromised patients 

In the South Africa 4,400 patients were enrolled. Remember that the new South African variant shows more variation in the spike protein. In that context 60% risk reduction for infection (95% CI: 19.9 – 80.1) was seen in the 94% of the study population that was HIV-negative. Twenty-nine cases were observed in the placebo group and 15 in the vaccine group. Only one placebo patient had severe disease. Crucially although including HIV positive patients reduced the efficacy shown, it still appears that the vaccine was of use to those patients who are in many cases immune compromised.

1/3 of the patients enrolled had evidence of prior COVID-19 infection which did not completely protect against subsequent infection by the South Africa escape variant. Vaccination with NVX-CoV2373 provided significant protection to these patients and those who had not previously been infected.

https://ir.novavax.com/news-releases/news-release-details/novavax-covid-19-vaccine-demonstrates-893-efficacy-uk-phase-3

J and J viral vector vaccine

This vaccines showed a good level of protection against moderate to severe COVID-19 infection 28 days after a single vaccination: 72% in the United States, 66% in Latin America and 57% in South Africa. (overall 66%). Thus we are still seeing efficacy in the Latin American and South African varients. Crucially, even with those variants circulating there were no COVID19 cases at all seen in vaccinated participants reported after day 49 thus showing increased efficacy over time after only one vaccine dose. It seems reasonable to hope that may also be the case with the other vaccines, again a small piece of evidence supporting the UK governments decision to delay second doses. And yet again no vaccinated patients were hospitalised or died of COVID19 after day 28. There is a huge amount of data building up that in adults of all ages the vaccines, at least in clinical trials, are preventing ALL hospitalisations and deaths from the disease. Clearly immune compromised patients are not typically included in the trials but if a blood cancer patient makes antibodies in response to one of these vaccines it does seem reasonable to at least hope that they are similarly protected.

Protection was seen across race, age groups, including adults over 60 years of age (N= 13,610), and across all variants and regions studied, including South Africa where nearly all cases of COVID-19 (95%) were due to infection with a SARS-CoV-2 variant from the B.1.351 variant.

The study enrolled 44% (N=19,302) of participants in the United States, 41% (N=17,905) in Central and South America (Argentina, Brazil, Chile, Colombia, Mexico, Peru) and 15% (N=6,576) in South Africa. 

Among participants globally, 59% are White/Caucasian; 45% are Hispanic and/or Latinx; 19% are Black/African American; 9% are Native American and 3% are Asian. In the United States, 74% are White/Caucasian; 15% are Hispanic and/or Latinx; 13% are Black/African American; 6% are Asian and 1% are Native American.

Study Safety Data
There were no significant safety concerns relating to the vaccine. 9% of patients experienced fever, and serious adverse events were higher in placebo. No anaphylaxis was seen. Like Astra-Zeneca, J and J is making this vaccine on a not-for-profit basis, and it does not require special deep freezing. Some patients had HIV (2.8%) and also other immunocompromised participants were allowed in the study.

Source: https://www.jnj.com/johnson-johnson-announces-single-shot-janssen-covid-19-vaccine-candidate-met-primary-endpoints-in-interim-analysis-of-its-phase-3-ensemble-trial

EU approves Oxford-AstraZenec vaccine.

In other news amidst arguments over supply, the EMA have also approved the Oxford vaccine several weeks after the UK. It is important that vaccines are made available all over the World, as we all stand or fall together in this pandemic.