LONDON – Controversy has erupted over COVID-19 vaccines dosing after the U.K. said it is to prioritize giving as many people as possible a single dose of the two currently approved products, rather than two doses three or four weeks apart, as scheduled on their labels. The move prompted a sharp rebuke from FDA Commissioner Stephen Hahn and Peter Marks, director of FDA’s Center for Biologics Evaluation, who said any such change “is not rooted in the science.”

Relief spread across the world in December when the first two mRNA COVID-19 vaccines received emergency use approvals, although that deep sigh was short-lived as a highly-transmissible SARS-COV-2 mutation began to make its rounds, highlighting the need for continued research to strengthen the arsenal.

Thanks to the pandemic caused by the SARS-CoV-2 coronavirus identified in late December 2019, 2020 was the year of COVID-19. It was a year of lockdowns and social distancing, a year of Zoom meetings and virtual conferences, and a year when donning a face mask sometimes came to signify a political rather than health decision. For the biopharma sector, the impact of COVID-19 was wide-ranging, in many cases showing the industry at its best, with the speedy mobilization of scientific efforts that spawned vaccine approvals at record rates and a host of therapeutics making their way through development. But biopharma suffered COVID-19-related setbacks as well, from a negative impact on clinical trials to the increasing politicization of science that could make the industry’s job harder as the world moves hopefully to end the pandemic in 2021. In looking back over the past year, BioWorld has compiled the biggest trends and lessons from the year of COVID-19.

Chinese regulators granted a first approval for general use to a COVID-19 vaccine to China National Biotec Group’s (CNBG) BBIBP-CorV. “The NMPA granted conditional approval to the vaccine on Dec. 30,” said Chen Shifei, deputy head of the National Medical Products Administration (NMPA) during a Dec. 31 press conference. The company is required to continue with phase III trials as planned, submit subsequent data and report any adverse reactions.

HONG KONG – China National Biotec Group (CNBG) said that BBIBP-CorV, one of the two COVID-19 vaccines it currently has under development, provides 79.34% protection against the coronavirus. Volunteers who received the vaccine in the phase III experiment produced high-tier antibodies, with a neutralizing antibody positive conversion rate of 99.52% after two doses, the company said.

LONDON – The COVID-19 vaccine developed by Astrazeneca plc and Oxford University has been approved by the U.K regulator, with the first doses being shipped on Dec. 30 and a mass vaccination program due to begin on Jan. 4. AZD-1222, now named COVID-19 Vaccine Astrazeneca, is authorized for emergency use and will require two doses for durable effect.

Hopes continue to rise as the COVID-19 vaccine beat goes on and Operation Warp Speed (OWS) lives up to its name, with Moderna Inc. netting another U.S. Department of Defense contract worth about $1.97 billion for another 100 million doses – an order that brings to about $6 billion the company’s government contracts for the product, which was granted emergency use authorization (EUA) earlier this month.

CAJICA, Colombia – The 33 countries across Latin America, Central America and the Caribbean are taking vastly different approaches to secure, acquire and distribute COVID-19 vaccines. A handful of the region’s wealthier countries have signed deals with vaccine suppliers or plan to manufacture them, but it is unclear how others will source or distribute vaccines to protect roughly 657 million people. Many are counting on the COVAX initiative.

The BioWorld Drug Developers index is currently tracking up more than 9% in value so far this month and is on target, with a handful of trading days left before the end of the year, to close up over 35% for 2020, well ahead of the general markets.