Coronavirus Breaking News

Brazil's Anvisa announced on June 15, 2021, it granted authorization for the exceptional importation of the Sputnik V vaccine by the Brazilian states of Rio Grande do Norte, Mato Grosso, Rondônia, Pará, Amapá, Paraíba and Goiás.

Anisa confirmed reduced quantities of Sputnik V doses to be imported for vaccination of 1% of the population of each state were also authorized. This decision empowers adequate monitoring and immediate action by the Agency, if necessary.

As decided on June 4, 2021, at the 9th Extraordinary Public Meeting of the Collegiate Board, the importation approved today must also be carried out under controlled conditions. For this purpose, the same responsibilities and conditions for the applicants were established.

Among other aspects highlighted in the Rapporteur's Vote, the main conditions provide that the vaccine should only be used in the immunization of healthy adult individuals. And all imported batches of vaccines can only be destined for use after release by Fiocruz's National Institute for Quality Control in Health.

Anvisa affirmed it may, at any time, suspend the import, distribution, and use of imported vaccines.

As of June 16, 2021, sixty-seven countries had authorized the Sputnik V Vaccine.

Maryland-based Novavax, Inc. announced that NVX-CoV2373, its recombinant nanoparticle protein-based COVID-19 vaccine, demonstrated 100% protection against moderate and severe disease, 90.4% efficacy overall, and met the primary endpoint in its PREVENT-19 pivotal Phase 3 trial.

The study enrolled 29,960 participants across 119 sites in the U.S. and Mexico to evaluate the efficacy, safety, and immunogenicity, emphasizing recruiting a representative population of communities and demographic groups most impacted by the disease.

The placebo-controlled portion of PREVENT-19 continues in adolescents from 12 to less than 18 years of age, which recently completed enrollment with 2,248 participants.

The company confirmed it intends to file for regulatory authorizations in the third quarter, upon completion of the final phases of process qualification and assay validation needed to meet chemistry, manufacturing, and controls requirements.

In March 2021, the European Medicine Agency started a rolling review of NVX-CoV2373 developed by Novavax CZ AS (a subsidiary of Novavax, Inc.).

Upon regulatory approvals, Novavax remains on track to reach a manufacturing capacity of 100 million doses per month by the end of the 3Q21 and 150 million doses per month by the end of the 4th quarter of 2021.

"PREVENT-19 confirms that NVX-CoV2373 offers a reassuring tolerability and safety profile," stated Gregory M. Glenn, M.D., President of Research and Development, Novavax, in a press release.

"These data show consistent, high levels of efficacy and reaffirm the ability of the vaccine to prevent COVID-19 amid ongoing genetic evolution of the coronavirus."

"Our vaccine will be a critical part of the solution to COVID-19, and we are grateful to the study participants and trial staff who made this study possible, as well as our supporters, including the U.S. Government."

Located in Gaithersburg, MD, Novavax, Inc. (NVAX) is a biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases.

The Kingdom of Saudi Arabia confirmed it has restricted the Hajj 2021 pilgrimage to citizens and residents and set a maximum of 60,000 pilgrims in response to the COVID-19 pandemic, reported Aljazeera on June 12, 2021.

“Those wishing to perform the hajj must be free of chronic diseases and be vaccinated,” and between the ages of 18 and 65, the Hajj ministry said in a statement.

And the Council of Senior Scholars has voiced support for the decision, citing the move's contributions to saving lives.

In a statement issued on June 12th, the Council noted that the decision to limit the Hajj for this year (1442 H/ 2021 AD) is part of the coronavirus-containment measures and is aimed at ensuring that Hajj is performed in a safe manner, adding that the decision is in line in line with the teachings of Islam in preserving the lives of human beings.

The statement cited the Holy Quran verses: "Do not throw yourselves with your own hands into destruction" and a Hadith warning: “If there is a plague in a town, no one should leave it or go into it.”

Citing experts' warning that large gatherings increase the risk of coronavirus infections, the Council described the Saudi government's decision to limit this year's Hajj as reasonable, responsible, and highly needed to protect human lives and ensure safe Hajj.

Hajj and Umrah are religious pilgrimages to Mecca, Saudi Arabia. Islamic religious doctrine dictates that every non-disabled adult Muslim who can afford to do so is obligated to make Hajj at least once in his or her lifetime.

Prof Ashok Rattan is a veteran medical microbiologist in India, wrote an article published by BioVoice on June 11, 2021, discussing how the 'Sputnik V vaccine could accelerate the vaccination drive in India.'

This article is excerpted below:

'India has acted as the hub for testing samples of the Sputnik V vaccine, also produced in the country. The country has taken the onus of producing millions of doses of the vaccine- both for local use and export.

This is to say that with India’s image as the world’s biggest vaccine maker and world-class production and export capabilities, it is the ideal partner to Russia’s long-standing track record as medical pioneers.

India’s vaccine policy has a sole purpose- to strengthen the whole vaccine program in the country.

As we know, vaccines have been one of the great public health tools in India, and the Indian vaccine industry has also made great inroads in the national and global vaccine scenario.

The focus should be now on continued evaluation of the policies to keep up with the volatile nature of the pandemic and to ultimately ensure that we come out of this stronger,' concluded Rattan's edited comments.

Prof Ashok Rattan was conferred APJ Abdul Kalam Award for Lifetime Contribution to Medical Sciences in 2018 and Shriniwas Oration in 2021 by the Indian Association of Microbiologists for his contribution to the laboratory diagnosis of Tuberculosis. Currently, he is an Advisor at Pathkind Laboratories.

The latest weekly surveillance report from Public Health England (PHE) shows that COVID-19 infection rates in north-west England increased over the last seven days to June 6, 2021.

This is the highest total for the region since late February 2021 and is also the highest of any region in England.

Furthermore, the latest figures show 906 COVID-19 patients in hospitals in England as of June 10th, up from 779 a week earlier.

PHE also said that case rates have risen among almost all age groups in England, with a spike in rates amongst 20 to 29-year-olds, going from 54.0 in the week ending May 30th to 121.0 in the seven days to June 6th.

Additionally, PHE estimates to May 30, 2021, based on the direct effect of vaccination and vaccine coverage rates, are that around 42,000 hospitalizations have been prevented in those aged 65 years and over in England due to the vaccination program. And, there is increasing evidence that vaccines prevent infection and transmission.

Three COVID-19 vaccines, Pfizer/BioNTech, COVID-19 Vaccine AstraZeneca, and COVID-19 Vaccine Moderna, are currently being used in the UK. All have been authorized for supply by the Medicines and Healthcare products Regulatory Agency (MHRA) following a thorough review of safety, quality, and efficacy information from clinical trials.

As of June 2, 2021, for the UK, 67,998 Yellow Cards have been reported for the Pfizer/BioNTech vaccine, 195,641 have been reported for the COVID-19 Vaccine AstraZeneca, 3,278 for the COVID-19 Vaccine Moderna, and 754 have been reported where the brand of the vaccine was not specified.

The MHRA has received 406 Yellow Card reports of suspected adverse reaction to the Pfizer/BioNTech vaccine in which the patient died shortly after vaccination, 863 reports for the COVID-19 Vaccine AstraZeneca, 4 for the COVID-19 Vaccine Moderna, and 22 where the brand of the vaccine was unspecified. The majority of these reports were in older adults or people with underlying illnesses.

It is important to note that Yellow Card data cannot derive side effect rates or compare the safety profile of COVID-19 vaccinations, says PHE.

Reuters reported that Germany’s vaccine advisory committee recommended on June 10, 2021, only adolescents with pre-existing conditions should be given the Pfizer-BioNTech COVID-19 vaccine.

Furthermore, Germany's doctors and patients should make informed decisions regarding vaccination exceptions to this new recommendation.

A meta-analysis published on April 27, 2021, by researchers at the German Diabetes Center found obese men with diabetes were 28% more likely to die from COVID-19.

The Munich-based Standing Committee on Vaccination (STIKO) is an independent advisory group that develops national recommendations for the use of licensed vaccines. STIKO recommendations are not legally binding, but by German law, they form the basis for the federal states’ vaccination guidance and the Federal Joint Committee’s vaccination directive.

BioNTech SE was the initial developer of the COVID-19 vaccine and is based in Mainz, Germany.

In the USA, the U.S. Food and Drug Administration issued emergency authorization to include people 12 years and older in the Pfizer-BioNTech vaccination program without limitation on May 10, 2021. And the European Medicines Agency issued authorization for this age group on May 28, 2021.

India's Prime Minister Narendra Modi announced on June 7, 2021, the central government would soon offer free COVID-19 vaccines to all adults.

“Whether it is the poor, the lower middle class, the middle class, or the upper-middle class, under the federal government program, everyone will get free vaccines (beginning June 21st),” Modi said on national television.

Under earlier policies, the federal government gave free vaccines to the elderly and front-line workers. Reports indicate India has administered over 223 million vaccinations, representing about 5% of the country’s population.

India has been inoculating its people with the CoviShield and Covaxin vaccines and intends to offer the Sputnik V vaccine in late June'21.

India’s revised National COVID Vaccination Program guidelines are found at this link.