Coronavirus Breaking News

The European Medicines Agency (EMA) announced its human medicines committee had started a rolling review of NVX-CoV2373, a COVID‑19 vaccine developed by Novavax CZ AS, a subsidiary of Maryland-based Novavax, Inc. NVX-CoV2373 is a prefusion protein coronavirus vaccine candidate made using Novavax’s proprietary nanoparticle technology, Matrix-M, an adjuvant to enhance immune responses and stimulate high levels of neutralizing antibodies.

A rolling review is a regulatory tool that EMA uses to speed up the assessment of a promising medicine during a public health emergency.

The Novavax rolling review will continue until enough evidence is available for a formal marketing authorization application. EMA will assess the vaccine’s compliance with the usual standards for effectiveness, safety, and pharmaceutical quality. While EMA cannot predict the overall timelines, it should take less time than normal to evaluate an eventual application because of the work done during the rolling review.

Massachusetts-based Moderna, Inc. announced the Swiss Federal Government had increased its confirmed order commitment from 7.5 million to 13.5 million doses of the COVID-19 Vaccine Moderna in Switzerland.

The Swiss Federal Government's initial procurement for 4.5 million doses was announced on August 7, 2020, and was subsequently increased to 7.5 million doses on December 8, 2020. The additional 6 million doses announced today will be delivered beginning in the summer of 2021, with an option to receive doses in the first half of 2022 as Moderna explores potential vaccine boosters to address emerging variants.

On January 12, 2021, Swissmedic authorized the COVID-19 Vaccine Moderna, according to the ordinary approvals procedure and based on a rolling submission of data and the totality of scientific evidence shared by the Company, including a data analysis from the pivotal Phase 3 clinical study announced on November 30, 2020.

“We are grateful for the confidence and support showed by the Swiss Federal Government as they increase their supply agreement with us,” said Stéphane Bancel, Chief Executive Officer of Moderna, in a press statement.

The Moderna COVID-19 Vaccine (mRNA-1273) is an mRNA vaccine candidate against the novel coronavirus SARS-CoV-2 encoding for a prefusion stabilized form of the Spike (S) protein.

Dynavax Technologies Corporation announced on February 1, 2021, the UK Government exercised its option to order an additional 40 million doses of France-based Valneva SE's SARS-CoV-2 adjuvanted vaccine candidate, VLA2001. This brings the total volume of the Valneva vaccine ordered by the UK Government to 100 million doses. The UK retains options over a further 90 million vaccine doses for delivery between 2023 and 2025.

VLA2001 is a Vero-cell-based, highly purified inactivated vaccine candidate against the novel coronavirus SARS-CoV-2 that causes COVID-19 in humans. VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, combined with two adjuvants, alum and CpG 1018.

In September 2020, the companies announced a commercial partnership for the supply of Dynavax's CpG 1018 adjuvant for use in VLA2001 to support Valneva's agreement with the U.K. government to provide up to 190 million doses of VLA2001 over a five-year period.

Thomas Lingelbach, CEO of Valneva, added in a press statement, “We are very pleased to extend our supply commitment to the UK. Assuming success, we believe that our vaccine, which has commenced commercial production at our site in Scotland, can make a major contribution to the UK’s vaccination efforts later this year as well as in 2022. This new development in our partnership underlines the need for our inactivated vaccine approach, and we will continue to work closely with the Vaccines Task Force on execution.”

Researchers at the University of Oxford published in Preprints with The Lancet on February 2, 2021, an analysis from the ongoing trials of the AZD1222 vaccine known as AstraZeneca COVID-19. They reveal that the vaccine efficacy is higher at longer prime-boost intervals.

And, that a single dose of the vaccine is 76% effective from 22- to up to 90-days post-vaccination.

In this non-peer-reviewed preprint, they report that the effect of dosing interval on efficacy is pronounced, with vaccine efficacy rising from 54.9% with an interval of fewer than six weeks to 82.4% when spaced 12 or more weeks apart.

Professor Andrew Pollard, Chief Investigator of the Oxford Vaccine Trial, and co-author said in a press release, ‘These new data provide important verification of the interim data that was used by regulators to grant the vaccine emergency use authorization."

‘It also supports the policy recommendation made by the Joint Committee on Vaccination and Immunisation (JCVI) for a 12-week prime-boost interval, as they look for the optimal approach to roll out, and reassures us that people are protected from 22 days after a single dose of the vaccine.’

The analysis authors also reported on the potential for the COVID-19 vaccine to reduce transmission of the SARS-CoV-2 virus, based on swabs obtained from volunteers in the UK arms of the trial with a 67% reduction after the first dose of the vaccine.

Basel-based Roche announced on February 1, 2021, it has obtained the CE mark for its new SARS-CoV-2 Rapid Antigen Test Nasal, which will become available by mid-February 2021.

Compared to the existing Roche SARS-CoV-2 Rapid Antigen Test, the SARS-CoV-2 Rapid Antigen Test Nasal collects the sample from the front area of the nose instead of the nasopharynx, resulting in a simplified and faster testing procedure. Whether the test could also be used without a healthcare professional's supervision will depend on local regulatory requirements.

“Rapid testing continues to play an important role in the fight against COVID-19, especially in places when laboratory testing is not available and quick results are needed, such as nursing homes, healthcare facilities, and schools,” said Thomas Schinecker, CEO Roche Diagnostics, in a press statement.

The launch is a partnership with SD Biosensor Inc., with whom Roche has also launched a SARS-CoV-2 Rapid Antibody Test in July and a SARS-CoV-2 Rapid Antigen Test in September 2020. SD Biosensor is currently preparing to submit an Emergency Use Authorisation to the U.S. Food and Drug Administration (FDA).

As of January 29, 2021, the FDA authorized 320 coronavirus diagnostic tests, including 238 molecular tests, 69 antibody tests, and 13 antigen tests during 2020. Furthermore, 32 molecular authorizations can be used with home-collected samples. There is one molecular prescription at-home test, one antigen prescription at-home test, and one over-the-counter at-home antigen test.

As scientific evidence continues to accumulate during the COVID-19 pandemic, clinical understandings about the SARS-CoV-2 virus has changed. According to a new article published by Nature on January 29, 2021, the majority of virus transmissions occur as a result of infected people spewing large droplets, and small particles called aerosols when they cough, talk or breathe.

Although possible, the surface transmission is not thought to be a significant risk of spreading this betacoronavirus.

That doesn’t mean that cleaning doorknobs and other surfaces are pointless, but scientists say it needn’t be a priority.

In fact, the US Centers for Disease Control and Prevention (CDC) clarified its guidance about surface transmission on October 5, 2020, stating that this route is “not thought to be the main way the virus spreads.” It now states that transmission through surfaces is “not thought to be a common way that COVID-19 spreads”.

The CDC continues to believe, based on current science, 'that people are more likely to become infected the longer and closer they are to a person infectious with COVID-19.'

The British Medical Journal (BMJ) stated 'people infected with the new coronavirus variant discovered in the South East of England (known as B.1.1.7 or VUI 202012/01) are more likely to have a cough, sore throat, fatigue, or myalgia than those infected with other virus variants. The B.1.1.7 variant is thought to be much more infectious and possibly more deadly—although this is still being investigated.

The Office for National Statistics reported on January 27, 2021, the data also shows that people in England with the new variant are less likely to experience a loss of sense of smell or taste.

These findings have prompted some doctors to call for the official covid-19 symptom list to be reviewed and potentially expanded, which has not happened in England since May 2020. The UK government currently advises that people get tested for covid-19 if they have a high temperature, a new, continuous cough, or a loss or change to their sense of smell or taste.