An independent safety board has reviewed all the available data on the AstraZeneca/Oxford University vaccine. The assessment concluded that there was no evidence that the adverse event was caused by the vaccine. As of today, the trials have restarted in all participating countries except the US. There does not appear to be any further impediment to restarting in the US, just approval bureaucracy. Importantly though, this does not mean that the adverse event was conclusively not vaccine-related, only that the random incidence of the problem without a vaccine is high enough that it is completely possible that this was unrelated to the vaccine. This is great news and keeps all 3 (and as of this week, 4) major vaccine trials on track for an initial public data analysis some time next month.
Additionally, Pfizer, the manufacturer of one of the other major candidate vaccines announced this week that their initial trials indicate that the vaccine meets safety thresholds. The next issue with this vaccine is its effectiveness.
Remember that effectiveness does not have to be complete prevention of the disease to declare victory. In some years, the flu vaccine only is about 40-50% effective against the circulating strains of that particular year, but this is still enough to significantly reduce the danger of flu to society.
Despite this good news about vaccines, the Director of the CDC, Dr. Robert Redfield, and Dr. Tony Fauci of NIH were both quoted this week as saying that it will be well into 2021 before we will be back to normal life. This was the major news outlets’ lead headline, drawing a sharp contrast to the President’s repeated statements that vaccine authorization was expected before the election on November 3rd. Reading further into the remarks, the stories are not that far apart. Emergency use Authorization in early November will mean that the manufacturing and distribution of vaccines can begin. Based on the typical annual flu vaccine timeline, this would mean that vaccines will begin to be available in quantity over the first quarter of next year, and effective heard immunity likely achieved sometime in the second quarter. If this happens, then all the statements will be true.
But the other important fact is that getting back to normal is not as simple as a flip of a switch. Given the growing number of naturally immune people combined with the people who will receive the vaccine, large swaths of the community will be able to get back to a more normal way of life over the course of the first quarter. People who are at-risk will still need to take precautions and may not be able to get back to their preferred lifestyle, but the overall risk will be steadily decreasing.
There is no significant new news on anti-viral drugs, but there is an intermediate therapeutic between anti-virals and immunizations. This is antibody therapy. There are two types of antibody therapy, convalescent plasma, which is taking antibodies from someone who has recovered from the virus, and the development of monoclonal antibodies grown in the lab. On that latter front, the pharmaceutical maker Eli Lily announced this week that infusion of their new antibody preparation reduces the need for both emergency room visits and hospitalization by over 70%. Typically, these antibody drugs are very expensive and nothing on cost has been released yet, nor has a target date for emergency use authorization. So, this one is still down the road, but a very positive development.
No significant news on testing except that the Abbott Labs rapid test which will give a reasonably reliable answer to the question of “am I infectious?” in just a few minutes for $5 has had all projected units for the rest of this year purchased by the US Government. Unfortunately, there are been no formal announcements from HHS on how this will be distributed, although an administration official said they will give priority to nursing homes, schools, and other high-risk populations, details are scant. No significant numbers of this test are expected in any setting before the middle of October.
Finally, a plea for everyone to get a flu vaccine. We know there is enough vaccine available in most of the country now, but if public awareness campaigns are effective, we may see something of a shortage as we get further into the season. Remember that an effective flu vaccine campaign in Australia and New Zealand, combined with the mitigation measures we are already using for COVID 19 reduced their flu rates and hospitalizations to almost zero. Please get a flu shot soon!