The pharma sector is preparing to release the next generation of Covid-19 vaccines that specifically target Omicron, the dominant strain of the virus around the world today.
Currently 66.4 percent of the world’s population has received at least one dose of a Covid-19 vaccine, however only 17.8 percent of people in low-income countries have received at least one dose.
Pfizer and BioNTech’s tweaked vaccine
Pfizer and BioNTech have released data evaluating the safety and efficacy of two Omicron-adapted Covid-19 vaccine candidates. One has been created to specifically target the Omicron BA.1 variant, while the other is a combination of the initial Pfizer-BioNTech Covid-19 vaccine and a new candidate that targets the spike protein of the Omicron BA.1 subvariant.
Data from their latest clinical trials found that a booster dose of both these candidates provided a substantially higher immune response against Omicron BA.1 compared to the companies’ current Covid-19 vaccine.
The trial assessed the vaccines on 1,234 people aged 56 or older. One month after administering, the shot targeting just the BA.1 Omicron provided between 13.5 and 19.6 times more immunity than pre-booster levels. The dose containing both the original vaccine and new version provided between 9.1 and 10.9 times more immunity. Both also provide protection against the Omicron BA.4 and BA.5 subvariants that have emerged more recently, however it is less effective against these.
The results will be shared with the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) on June 28, to discuss updating vaccines later this year.
“Based on these data, we believe we have two very strong Omicron-adapted candidates that elicit a substantially higher immune response against Omicron than we’ve seen to date,” Albert Bourla, Chairman and Chief Executive Officer at Pfizer.
“We look forward to discussing these data with the scientific community and health authorities so we may rapidly introduce an Omicron-adapted booster as soon as possible if authorized by regulators.”
Moderna’s Omicron vaccine
Moderna has also updated its vaccine to target the Omicron subvariant. The company said its redesigned 50 microgram booster dose provides a higher antibody response against the Omicron variant one month after administration compared to its original vaccine. It was generally well-tolerated among 437 taking part in a clinical study, with side effects comparable to Moderna’s first vaccine.
Stéphane Bancel, Chief Executive Officer of Moderna, commented on the results: "Looking at these data alongside the durability we saw with our first bivalent booster candidate, mRNA-1273.211, we anticipate more durable protection against variants of concern with mRNA-1273.214, making it our lead candidate for a fall 2022 booster.
“We are submitting our preliminary data and analysis to regulators with the hope that the Omicron-containing bivalent booster will be available in the late summer,” he added.
Sanofi and GSK release results of Beta vaccine
Meanwhile, Sanofi and GSK have announced positive results from the late-stage trial of their next-gen Covid-19 vaccine. Modelled on the Beta variant antigen, it has been designed to protect against both the original strain of the Covid-19 virus and the Beta variant.
The study found that primary vaccination with this vaccine candidate provides 64.7 percent efficacy against infection in adults and 75.1 percent in people who have previously been infected with Covid-19.
Additionally, it is 72 percent effective against Omicron in all adults, rising to 93.2 percent in adults who have previously been infected with the subvariant. The two companies are hoping to commercialize the vaccine by the end of the year.
Roger Connor, President of GSK Vaccines, said: “These positive data show efficacy of our protein-based, bivalent adjuvanted vaccine candidate in an environment of high Omicron variant circulation.”
Following discussion with the regulatory authorities Connor said the aim is to make the vaccine candidate available later in 2022.
Quick links:
- Pfizer to supply all its medicines to low-income countries for no profit
- A post-pandemic 3D view of the patient and supply journey
- Why R&D must digitalize and become data-centric
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