As we enter 2021 Volume 3 reviews Emergency Use Authorization approvals as the world scrambles to vaccinate as quickly as possible.
We enter 2021 with the Covid pandemic in a third and even larger surge worldwide, with many countries enforcing unprecedented lockdown measures.
Globally confirmed infections are likely to exceed 100 million, and 2 million deaths, by month end. This compares with 50 million cumulative confirmed cases in the first week of November, and just over 1 million cumulative deaths at the start of October - a doubling of cumulative deaths in approx.100 days.
There is now a worldwide scramble to vaccinate as quickly as possible, as the emergency use of a number of vaccines is approved, against a backdrop of a global shortage of vaccines, and a loosening of previously inviolable medical and regulatory standards.
Following the FDA granting Emergency Use Authorization (EUA) for the Pfizer BioNTech and Moderna vaccines in mid-December, there has been a rush to approve these and other vaccine candidates in other countries.
The UK and India both granted EUA to the AstraZeneca Oxford vaccine, despite issues with the Stage 3 trials.
India also gave conditional approval to the domestic Bharat Biotech’s Covaxin WIV vaccine, notwithstanding incomplete Stage 3 data.
Dr Slaoui said on CBS Face the Nation that there are discussions with the FDA re cutting the Moderna dose in half for the under 55s to increase availability. This is based on some limited data from the Stage 1/2 trial, but this protocol was not tested in the Stage 3 trial.
China gave the first general public use authorization of any vaccine worldwide to the Sinopharm WIV vaccine. China says that 4.5 million vaccinations have already been given in China, and set a target of 50 million vaccinations by Chinese New Year on February 6th, at a current rate of approx 1 million per day (or about 70 per 100,000 per day).
A number of major countries are now approaching vaccination of 1% of their population. Among smaller countries Israel has vaccinated 10% of its population, and Bahrain is reaching 4%. Many countries have experienced significant distribution and logistical issues even when vaccine supplies are available. In the US 14 million vaccines have been distributed to date, but only 4 million administered.
Daily rates of vaccination per 100,000 in late December have been 608 in Israel, 263 in Bahrain, 60 in the UK, 49 in the US, and 10 in Canada.
Vaccine efficacy reported from official Stage 3 trials is 94/95% for mRNA - Pfizer and Moderna; 79% for WIV - Sinopharm; and 62% for Adenovirus - AstraZeneca Oxford. (The British regulators did not accept AstraZeneca’s claim of a higher rate as statistically valid, and did NOT approve a half dose/full dose regime which accidently produced this result in a small sample of younger healthy people.)
Dr Fauci has revised his estimate for herd immunity upwards from 60-70% to 70-80% of the total population.
The new British mutation of the dominant G strain has now appeared in many other countries. Vaccine manufacturers are hopeful that the current generation of vaccines, all developed against the original D strain, will still provide protection, but acknowledge that updated versions may become necessary in the future.
Valneva, the French company developing a WIV vaccine with support from the British government, has announced plans for a US IPO.
The Ukraine announced the purchase of 1.9 million doses from Sinovac, at a price of $18 per dose.
The Serum Institute of India (SII) is finalizing a sale of 100 million doses, that it is manufacturing of the AstraZeneca vaccine, to the Indian government at just under $3 per dose, but said its price for commercial sales will be 5 times higher (approx $15 per dose).
Hong Kong has announced plans to acquire 7.5 million doses each of Pfizer (mRNA), Sinovac (WIV) and AstraZeneca (Adenovirus), and to allow consumer choice of vaccine.