Omicron Archives - Page 2 of 2 - Medical Design Sourcing

Molnupiravir holds up to omicron in lab studies

Merck & Co. (NYSE:MRK) and its partner Ridgeback Biotherapeutics have shared data from six preclinical studies showing that the COVID-19 pill molnupiravir was active against the omicron variant in vitro.

The two companies continue to seek regulatory authorization for the drug internationally, which is currently authorized in more than 10 countries, including the U.S., the UK, Taiwan, Japan, India and Australia.

“Based on its mechanism of action, along with these new findings demonstrating in vitro activity across multiple variants, including omicron, we anticipate that molnupiravir will continue to be active against variants of concern and an important tool in the fight against COVID-19,” said Wendy Holman, Ridgeback Biotherapeutics CEO, in a statement. “We are grateful for the efforts of the investigators and look forward to continuing our work to help address the pandemic.”

The recent lab studies were conducted by independent researchers using cell…

FDA authorizes expanded use of Pfizer-BioNTech vaccine boosters

With the U.S. facing the biggest surge of COVID-19 infections to date, the FDA has decided to amend the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to cover adolescents aged 12 to 15 and for some immunocompromised children between the ages of 5 and 11. The agency has also reduced the window between the second and third doses from six to five months.

“With the current wave of the omicron variant, it’s critical that we continue to take effective, life-saving preventative measures such as primary vaccination and boosters, mask-wearing and social distancing in order to effectively fight COVID-19,” said Acting FDA Commissioner Dr. Janet Woodcock.

To arrive at its decision, FDA analyzed real-world data from Israel, including 6,300 individuals between the ages of 12 and 15 who received a booster dose of the BNT162b2 vaccine at least five months after receiving a second dose.

The authorization for certain immunocompromised child…

Israel plans to authorize fourth COVID-19 vaccine dose for high-risk populations

Photo by Frank Meriño from Pexels

Mere months ago, health experts were divided on whether COVID-19 boosters were necessary for the broader public.

Then came delta and then came omicron.

Now Israel is moving to become one of the first countries to offer a fourth dose of COVID-19 vaccine to people at least 60 years old and those at high risk of severe disease. Countries such as Switzerland and the U.K. have reduced the window of time for booster eligibility from six months down to four and three months, respectively.

As a result, COVID-19 vaccines from companies such as Pfizer and its partner BioNTech, Moderna and others continue to be a hot commodity.

A number of companies, including Pfizer and Moderna, are also developing omicron-specific versions of their vaccines. Both of those companies are gearing up for clinical trials in early 2022.

Earlier this month, Pfizer CEO Dr. Al…

Sotrovimab wins EU marketing Authorization as an early COVID-19 therapy

GlaxoSmithKline (LSE/NYSE:GSK) and its partner Vir Biotechnology (NSDQ:VIR) have received marketing authorization from the European Commission for the dual-action monoclonal antibody Xevudy (sotrovimab).

The marketing authorization covers individuals 12 and older who weigh at least 40 kg who do not need supplemental oxygen. It also requires that such individuals have a heightened risk of developing severe COVID-19.

This summer, GSK and VIR had reached a joint procurement agreement with the EC involving 220,000 doses of the drug.

“With today’s marketing authorization we are now able to expand access, and we are discussing with governments how we can bring sotrovimab to more patients,” said Dr. Hal Barron, chief scientific officer and president R&D of GSK, in a statement.

The two companies also have revealed that preclinical data suggest that sotrovimab retains activity against the Omicron variant, which threatens to become the dominant form of …

Pfizer to test a third dose of COVID-19 vaccine in children 6 months to under 5 years of age

Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) have found that two 3-µg doses of their BNT162b2 (Comirnaty) vaccine were safe but generated an underwhelming immune response in children aged two to five years old.

PFE shares fell 2.45% to $59.75 in early afternoon trading.

The news could delay vaccine availability for younger children.

As a result, the companies plan on amending a clinical trial to test a third dose of the vaccine at least two months after the second dose.

Pfizer notes that the Phase 1/2/3 study is ongoing and is still blinded.

Pfizer noted that similar clinical data in older age demographics showed higher efficacy with two doses — albeit at higher doses.

On a positive note, a third dose of the vaccine was well tolerated in the trial involving two to five-year-olds.

The companies plan on filing for emergency use authorization in children aged 6 months to under 5 years if the third dose is efficacious. Read more

Regeneron readies new COVID-19 monoclonal antibodies after the emergence of Omicron

Regeneron Pharmaceuticals (NSDQ REGN) plans to develop antibodies that hold up to the Omicron SARS-CoV-2 variant. Lab results from German researchers indicate that the company’s REGEN-COV/Ronapreve (casirivimab and imdevimab) antibody cocktail lost potency against the variant.

REGN shares fell almost 4% to $631.74 today.

“Our antibody cocktail works against Delta. Delta is still surging,” said Dr. Len Schleifer, CEO of Regeneron, in an interview with CNBC. “But if Omicron starts to surge, we need antibodies that work against Omicron.”

The company has a “whole host” of antibodies in its pipeline that could work against Omicron and Delta.

WHO has reported that Omicron is spreading faster than earlier strains when they first emerged.

The variant makes up roughly 3% of U.S. cases at present.

Three doses of Pfizer-BioNTech vaccine neutralized Omicron variant in the lab

Pfizer (NYSE:PFE) and BioNTech SE (NSDQ:BNTX) have announced that their vaccine remains effective against the Omicron variant (B.1.1.529 lineage) of SARS-CoV-2 in early lab studies.

Two doses of the vaccine significantly reduced neutralization titers, while three neutralized the variant.

The lab studies showed that three doses of the BNT162b2 vaccine were similar in efficacy against Omicron as two doses were against the wild-type SARS-CoV-2 spike protein.

Pfizer and BioNTech indicated that two doses of the BNT162b2 are likely insufficient to prevent infection from the Omicron variant. However, the companies still expect that two doses of the vaccine will be effective at protecting against severe disease related to the Omicron variant.

Early evidence suggests that Omicron may offer less of a risk of severe disease than the Delta variant, which continues to dominate the U.S.

“Although two doses of the vaccine may still offer protection agains…

GSK and Vir upbeat about efficacy of sotrovimab against Omicron

GlaxoSmithKline (LON:GSK) and its partner Vir Biotechnology (NSDQ:VIR) have announced that their COVID-19 drug sotrovimab continues to offer protection against the mutations in the spike protein of the Omicron SARS-CoV-2 variant.

In March, the two companies received emergency use authorization (EUA) for the drug. The EUA specifically covers the treatment of mild-to-moderate COVID-19 in high-risk adults and children.

Drawing on preclinical research, the two companies suggest that at least one dose of sotrovimab would protect against Omicron, which WHO has categorized as a variant of concern. The preclinical research involved pseudo-virus testing, including 37 mutations in the Omicron variant spike protein.

Formerly known as VIR-7831, sotrovimab is a monoclonal antibody.

The antibody is the first with “preclinical data demonstrating activity against all tested SARS-CoV-2 variants of concern and interest to date, including Omicron, as well as the sti…

J&J joins Moderna and Pfizer in researching Omicron variant

Johnson & Johnson (NYSE:JNJ) has announced that it is collaborating with academic institutions internationally to gauge the effectiveness of its COVID-19 vaccine against Omicron and other SARS-CoV-2 variants.

In particular, J&J said it is conducting research on blood serum from clinical trial volunteers who have received single or multiple doses of its COVID-19 vaccine.

The company also vowed to design and develop an Omicron-specific variant vaccine if necessary.

“We remain confident in the robust humoral and cell-mediated immune responses elicited by the Johnson & Johnson COVID-19 vaccine demonstrated by the durability and breadth of protection against variants to date in clinical studies,” said Dr. Mathai Mammen, global head, Janssen Research & Development, in a press release. “Building on our long-term collaboration with scientists on the ground in South Africa and the ongoing real-world effectiveness studies being conducted with the J…

Pfizer and Moderna keeping a close watch on Omicron COVID-19 variant

Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA) are planning to research their vaccines’ effectiveness against the highly mutated Omicron variant (B.1.1.529), which is behind a surge in infections in Johannesburg, South Africa. If needed, they plan to create new versions of their vaccines.

The Omicron variant has more than 30 changes to the SARS-CoV-2 spike protein.

“I don’t think the result would be the vaccines don’t protect,” Pfizer CEO Dr. Albert Bourla told CNBC. It is possible, however, that the vaccines could offer less protection against Omicron than other variants such as Delta.

Get the full story from our sister site, Drug Discovery & Development.