Omicron Variant has Vaccine Makers Moving Fast and More COVID News
Over the holiday weekend, the news that a new variant of concern (VOC) of the COVID-19 virus dubbed Omicron has caused several countries, including the U.S., to install travel bans against several South African countries where the virus appears to originate. It has also caused vaccine makers to rush to test their vaccines against it. For that news and more, continue reading.
Vaccine Makers Scramble to Test for New Variant of Interest, Omicron
Over the Thanksgiving weekend in the U.S., the World Health Organization (WHO) declared a new strain of SARS-CoV-2 to be a variant of concern. The U.S., Canada and the UK enacted travel bans on eight southern African countries, including South Africa, Botswana, Zimbabwe, Namibia, Lesotho, Eswatini, Mozambique and Malawi. The strain, B.1.1.529, has been classified as Omicron. Not much is known about the strain, except that about half of its spike protein has mutated, which drives concerns over whether it can evade vaccines and antibody therapies.
Now that other countries are looking for it, Omicron has been identified in about 17 countries. Largely anecdotal so far, a South African physician who first reported the Omicron variant said it presents “unusual but mild” symptoms. Angelique Coetzee, a board member of the South African Medical Association, told The Telegraph, “It presents mild disease with symptoms being sore muscles and tiredness for a day or two not feeling well. So far, we have detected that those infected do not suffer the loss of taste or smell. They might have a slight cough. There are no prominent symptoms. Of those infected some are currently being treated at home.”
Novavax indicated on Friday, November 26, that it had begun work on a version of its COVID-19 vaccine that will target the latest variant of concern, Omicron. They expected to have it ready to test and produce in the next few weeks. Their COVID-19 vaccine contains actual viral spike protein.
“The initial work will take a few weeks,” a company spokesperson said.
Pfizer, BioNTech and Moderna have all said they have begun testing their mRNA vaccines against Omicron to determine if any adjustments to their vaccine formulas need to be made. They expect results in about two weeks.
Stephane Bancel, chief executive officer of Moderna, said it would take months to develop and distribute a vaccine that specifically targets Omicron. But a 100-microgram booster shot of the original vaccine — the typical booster dose is 50 micrograms — could be available much sooner.
“The higher dose could be done right away but it will be months before the Omicron specific variant is ready to ship in massive quantities,” Bancel told CNBC’s “Squawk Box.”
BioNTech has indicated it is both testing its original vaccine on Omicron as well as starting to develop a modified version “in order not to waste any time.” The company indicated it would be able to distribute new versions of the vaccine within 100 days if a new variant presented itself.
Thermo Fisher Scientific Reports its PCR Tests Detect Omicron Variant
Thermo Fisher Scientific confirmed that two of its polymerase chain reaction test kits, TaqPath COVID-19 Combo Kit and TaqPath COVID-19 CE-IVD RT-PCR Kit, provide accurate tests results, including the Omicron variant. The variant has more than 30 mutations in the spike protein alone, and the WHO and European Centers for Disease Control have reported that PCR tests that use S-gene target failure (SGTF) as a proxy for the variant helped identify Omicron. The Thermo Fisher assays detected Omicron by identifying three gene targets from the virus's orf1a/b, S, and N regions. The S gene target is affected by Omicron, but ortf1a/b and N gene targets do not appear to be impacted by any of the Omicron variant mutations.
NRx’ BriLife COVID-19 Vaccine Effective Against Delta and Wildtype Strains
NRx Pharmaceuticals reported that the Israel Institute for Biological Research (IIBR) announced the effectiveness of the BriLife vaccine against the Delta variants of COVID-19 in early studies. NRx is developing the vaccine, which the Israel Institute for Biological Research originally developed.
The study was on an initial sample of 11 trial participants’ blood. The vaccine demonstrated effective neutralizing antibodies against the Wuhan wild-type virus and then tested for the Delta variant antibodies. Ten of the 11 samples were shown to neutralize Delta. The second group of blood samples was from unvaccinated patients who had COVID-19 and recovered. Their antibodies against the wild-type strain were effective but dropped by 3.8-fold to the Delta variant.
FDA Places Clinical Hold on Ocugen’s COVID-19 Vaccine
Ocugen reported the U.S. Food and Drug Administration (FDA) had issued a clinical hold on its Investigational New Drug application (IND) to evaluate its COVID-19 vaccine, BBV152 (Covaxin). The vaccine is an investigational vaccine in the U.S., developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). It has emergency use authorization in 17 countries. Ocugen and Bharat Biotech are co-developing the vaccine in the U.S. and Canada. No details have been provided on why the agency issued the hold.
Many People Choose Other Vaccines than J&J’s as Boosters
Although touted earlier as being advantageous because it only required a single dose, the Johnson & Johnson vaccine has a lower efficacy than the mRNA vaccines developed by Pfizer-BioNTech and Moderna. In the Phase III ENSEMBLE trial, it demonstrated 66% effectiveness overall in preventing moderate-to-severe COVID-19, 28 days after vaccination, and 100% efficacy at preventing severe disease after day 49.
In October, the company submitted data to the FDA and CDC on using the J&J vaccine as a booster dose, that the second shot was associated with 94% vaccine efficacy for all age groups. The company also argues that the vaccine efficacy doesn’t wane over time, like the Pfizer-BioNTech and Moderna vaccines appear to do, although they both had higher efficacy initially than the J&J vaccine. A real-world study of the J&J vaccine with a single shot showed 71% effectiveness against hospitalizations in U.S. adults compared to 93% for Moderna and 99% for Pfizer-BioNTech. Some public health and vaccine experts have felt the J&J vaccine should have always been a two-dose regimen.
Data suggests that people who originally received the J&J vaccine tend to select the Moderna or Pfizer-BioNTech vaccines for their booster shots.