Almost a year into the pandemic, a world facing the unrelenting spread of the coronavirus received a burst of good news, with a vaccine developed by Pfizer Inc. showing “extraordinary” results while an antibody therapy from Eli Lilly & Co. was granted emergency-use authorization in the U.S.
The double shot of progress was somewhat offset by news that the final-stage trial of a frontrunner Chinese vaccine candidate was halted in Brazil due to a serious adverse event, the first time that the Asian nation’s rapidly ascendant shots have met such a setback.
Though the reaction across markets worldwide remained overwhelmingly positive — a global rally added more than $1.8 trillion to the value of the MSCI All Country World Index — the reality is that significant uncertainty remains in the race for immunization.
China has already administered its shots, including the one from Sinovac Biotech Ltd. whose trial was just paused in Brazil, to hundreds of thousands of people under an expansive emergency use program. The halt now underscores the risks of governments acting on early positive data to greenlight shots without a long-term understanding of the vaccines’ safety profiles.
Development processes that usually take years have been compressed into months, and experts caution that the world is in uncharted territory with Covid-19 vaccines.
Who’s Got the Shot?
Countries with vaccine orders from Pfizer and Moderna.
Still, the preliminary data disclosed by Pfizer was so unexpectedly positive that it overwhelmed all caveats, sending investors stampeding out of haven assets like the yen and Treasuries and into securities most exposed to an economic recovery. With control of the coronavirus seemingly all but lost in the U.S. and parts of Europe, Pfizer’s vaccine and the experimental genetic technology it harnesses was received like a deus ex machina.
The 13 economies that have already inked supply agreements with Pfizer and its German partner BioNTech SE are now poised advantageously. Pfizer and BioNTech have said they should be able to produce 1.3 billion doses of their shot — enough to vaccinate 650 million people — by the end of 2021. About 50 million doses are expected to be available in 2020.
At least four countries also have agreements with Moderna Inc., whose vaccine uses the same experimental mRNA technology that Pfizer does. The company is expected to release preliminary data soon.
The U.S. and Japan have the most total orders for both mRNA vaccines — 200 million and 170 million respectively — while even developing nations like Peru and Ecuador have orders in for Pfizer’s shot.
Meanwhile, the U.S. Food and Drug Administration’s approval of Eli Lilly’s antibody therapy for use against mild-to-moderate Covid-19 provides another weapon in doctors’ arsenal to treat the coronavirus.
Attention is now turning to the significant challenges ahead, especially in how to deploy mRNA vaccines given their unusual requirement for cold storage and transportation. They must be stored in deep-freezer conditions of -70 degrees celsius, facilities that even many major hospitals don’t have — not to mention developing countries where electricity is intermittent.
Two-shot vaccines are also difficult to administer in some populations where people are not easily contactable, or have to travel long distances to reach vaccination centers.
Pfizer’s news “is very encouraging, however, it will not, on its own, mean that we will be able to resume ‘business as usual’ any time soon,” said Linda Selvey, an infectious diseases epidemiologist at the University of Queensland in Australia.
She said it’s important to have several vaccines available “in order to ensure that everyone around the world will be protected.”
In the U.K., the Medicines and Healthcare Products Regulatory Agency in U.K. has started a rolling review of Pfizer’s vaccine, allowing regulators to see clinical data in real time so that approvals can be granted more quickly. That could make the shot available in the country ahead of the European Union.
Shanghai Fosun Pharmaceutical Group Co., which has licensed the Pfizer shot for mainland China and Hong Kong, is planning to conduct supplementary trials locally to get the vaccine approved for mass use by China’s regulator, the National Medical Products Administration.
China has already granted its three homegrown developers emergency use approval and hundreds of thousands of people have been dosed. Doubts had been growing that the Chinese companies could distribute to so many without any serious adverse events occurring when Brazil paused Sinovac’s trial after an incident on Oct. 29 for investigation.
A researcher with Sao Paulo’s Instituto Butantan, which partnered with Sinovac to produce the vaccine locally, said that a trial participant had died and that the death is not related to the vaccine. AstraZeneca Plc and Johnson & Johnson have also paused their trials in recent months to investigate serious adverse events before re-starting them.
Still, if serious safety concerns are subsequently found with any vaccine, it will be too late for many.
“The key question still centers upon time,” said Michael Kinch, a vaccine specialist at Washington University in St. Louis. “It will be crucial to track safety and efficacy over the coming weeks and months. If nothing else, we have learned that we need to look to the long term.”