Coronavirus Breaking News

A meta-analysis published on April 28, 2021, based on 22 studies conducted by researchers at the German Diabetes Center, found men with diabetes were 28% more likely to die from COVID-19 than diabetic women were.

And, people with diabetes aged over 65 with diabetes were more than three times more likely to die than younger patients were.

Professor Michael Roden, a scientific director and board member of the German Diabetes Center, said in a related press statement, "These results will help classify individuals with diabetes even better to improve their therapy and mitigate the course."

The Sputnik V Vaccine.com website published a rebuttal to the decision by Brazil’s National Health Surveillance Agency (Anvisa) to delay the approval of the Sputnik V vaccine on April 28, 2021. This statement is excerpted below:

The Anvisa regulator’s decision contradicts an earlier decision by Brazil’s Ministry of Science, Technology, and Innovation, which recognized the Sputnik V vaccine as safe and permitted its production in Brazil.

The Sputnik V team has addressed the technical issues raised by Anvisa board members during the meeting on April 26, 2021, to demonstrate that these allegations have no scientific grounds.

1. The Gamaleya Center, which carries out strict quality control of all Sputnik V production sites, has confirmed that no replication-competent adenoviruses (RCA) were ever found in any of the Sputnik V vaccine batches that have been produced. Existing quality controls ensure that no RCA can exist in Sputnik V vaccine. Before an inspection, the Anvisa team received an official letter from the Gamaleya Center dated March 26, 2021, which clearly says: “In addition, we would like to inform you that during the release of the vaccine product at the Center site and at the contract site of JBC Generium, not a single batch containing RCA was recorded.”

2. The quality and safety of Sputnik V are, among other things, assured by the fact that, unlike other vaccines, it uses a 4-stage purification technology that includes two stages of chromatography and two stages of tangential flow filtration. This purification technology helps to obtain a highly purified product that goes through mandatory quality control, including control for RCA or any additives presence. Control for RCA is carried out not only for the finished product but also at all stages of production, including the viral seed. Sputnik V team believes that its purification technology is the best among all vaccines and is one of the pillars for vaccine safety.

3. Only E1 and E3 type non-replicating adenoviral vectors, which are harmless for the human body, are used in the Sputnik V vaccine production.

4. Anvisa team in Moscow had full access to all the relevant documents and research and production sites. All the relevant scientific documents and data and direct access to the Gamaleya Center scientists in charge of the vaccine development were made available to the Anvisa team.

5. In response to queries about the sterilization processes validation, the manufacturing sites that were being inspected provided risk assessment protocols and the official commitment letter that clearly said that validation of sterilizing filtration would be performed and results provided to ANVISA.

6. The inspection scope included only the two production sites from which the deliveries to Brazil are planned.

The safety and efficacy of the Sputnik V have been confirmed by 61 regulators in countries where the vaccine has been authorized with the total population of over 3 billion people. After vaccination of 3.8 million people, the real-world study in Russia demonstrated the Sputnik V efficacy at 97.6%.

Several independent real-world studies in countries (Hungary, Mexico, Argentina) where the vaccine is being used in mass vaccination programs show strong evidence confirming Sputnik V’s efficacy and safety.

Furthermore, unlike with other vaccines, there were no cases of cerebral venous sinus thrombosis during the use of Sputnik V.

The Sputnik V team will continue to work with the government of Brazil, the individual states, our Brazilian partner União Química, which is ready to launch large-scale production of the vaccine, as well as with all other parties in Brazil to save lives.

Moreover, the Sputnik V team believes in constructive cooperation between countries to help the world to defeat the pandemic,' concluded the statement.

The Government of Japan reimposed a state of emergency for Tokyo, Osaka, Hyogo, and Kyoto prefectures effective April 25, 2021, This declaration is scheduled to terminate on May 11 but could be extended further, stated the US Embassy in Japan's Health Alert.

The COVID-19 pandemic continues to increase in many parts of Japan, not just those included in the recent state of emergency declaration. The third state of emergency during the COVID-19 pandemic urges residents to take all possible precautions against the spread of the SARS-CoV-2 coronavirus.

On April 26, 2021, the U.S. Embassy strongly urged U.S. citizens to monitor local news for updates to guidance for their area and comply with all local and national COVID-19 mitigation measures.

The Government of Japan continues to enforce strict travel regulations that prohibit most new foreigners from entering Japan. Foreign tourists and non-resident foreign business travelers remain prohibited from entering Japan.

Japanese citizens and foreign residents with a reentry permit are generally allowed to reenter Japan. Still, they must comply with strict pre-and post-travel testing requirements and self-quarantine upon arrival.

Regardless of the international point of origin, all travelers entering Japan remain subject to a 14-day self-quarantine upon arrival and are prohibited from using public transportation to include domestic flights, taxis, and rail.

Travelers arriving from certain areas or without proof of pre-departure COVID-19 testing may be required to quarantine for a period of time in a government-designated location. U.S. military and SOFA status personnel should speak with their command about upcoming travel, COVID-19 testing, and any restriction of movement (ROM)/quarantine requirements.

All travelers inbound to Japan must receive a negative PCR test within 72 hours of flight departure. These tests must be presented in the prescribed format and must comply with rigorous requirements. For information, please see the Ministry of Foreign Affairs website.

The U.S. Embassy and consulates are open for routine services, but appointment availability remains limited. Availability will be even more limited during Japan’s Golden Week celebrations. To schedule an appointment, visit this website for instructions.

Hyderabad-based Natco Pharma Limited announced today it has applied to the Central Drugs Standard Control Organization (CDSCO) in India to approve Phase III clinical trial of Molnupiravir Capsules for the treatment of COVID-19 patients.

Molnupiravir (MK-4482, EIDD-2801) is an experimental oral antiviral originally developed to treat influenza. It is an orally active prodrug of the synthetic nucleoside derivative N4-hydroxycytidine and exerts its antiviral action by introducing copying errors during viral RNA replication.

Patients treated with Molnupiravir have achieved response within 5 days of therapy, indicating that the duration of treatment with Molnupiravir is short, with the additional advantage of being an oral therapy.

Molnupiravir was originally developed at Emory University in Georgia and was later acquired by Ridgeback Biotherapeutics, which partnered with Merck & Co.

NATCO stated in a press release it 'is hoping that CDSCO would give emergency approval of this drug based on “compassionate use” for patients. “Compassionate use” approval is given for investigational drugs so a patient with an immediately life-threatening condition can gain access to the drug.'

NATCO confirmed it is ready to launch Molnupiravir this month if approval is given.

Natco Pharma Limited was incorporated in India in 1981 and today has seven manufacturing facilities spread across India with dedicated modern research laboratories, capabilities in New Drug Development.

The U.S. CDC issued a Level 4 Travel Alert for India on April 19, 2021, confirming a very high level of COVID-19 infections in India. The CDC says that even fully vaccinated travelers may be at risk for getting and spreading COVID-19 variants because of the current situation.

'If you must travel to India, get fully vaccinated before travel.'

Regarding international travel, the CDC says, 'if you are fully vaccinated, you do not have to get tested before leaving the USA unless your destination requires it. And you do not have to self-quarantine after you arrive in the USA.'

But, all air passengers coming to the USA, including U.S. citizens and fully vaccinated people, must have a negative COVID-19 test result in no more than 3 days before travel or documentation of recovery from COVID-19 in the past 3 months before they board a flight to the USA, says the CDC.

The United States government previously committed additional medical aid to fight the spike in COVID-19 cases in India. And on April 26, 2021, the US government announced it would release 60 million doses of AstraZeneca's COVID-19 vaccine to other countries over the next several months.

'The Biden administration's commitment to export raw materials for the Indian manufacturer of the Covishield vaccine is a welcome decision,' commented Indian American Congressman Raja Krishnamoorthi, speaking to PTI News. 'However, this is no time for symbolism, half-measures, or lip service. We must act now,' he asserted on April 26th.

The U.S. response comes after Britain, France and Germany pledged aid to India over the weekend, reported CNBC.

A professor with the Academician of the Russian Academy of Sciences announced on April 26, 2021, the time between the first and second dosing of the Sputnik V Vaccine can be extended.

"We believe it is possible to increase the minimum interval between the first and second vaccine shots from the earlier approved 21 days up to three months," stated Alexander Gintsburg, M.D., in a press release. "Extending the interval will not affect the vaccine-induced immune response, and, in some cases, will enhance and prolong it."

The press statement added 'the conclusion comes from our experience in using vaccines using the identical adenovirus platform and, most importantly, from successful mass vaccination campaigns in Russia and numerous other countries. As the Sputnik V vaccine developers, we also support the earlier, independently made statements by respected health regulators, such as the ANMAT (Argentina), on extending the interval between shots.'

"We also believe that, given the exceptionally high demand for the vaccine among the population, this decision would significantly expedite immunization. We believe that it is up to each national regulator to decide whether to retain the 21-day interval between shots or to extend it to up to 3 months," concluded Dr. Gintsburg's comments.

The Sputnik V (Gam-COVID-Vac) is a two-part vaccine that uses a weakened virus to deliver small parts of a pathogen and stimulate an immune response. It is a vector vaccine based on adenovirus DNA, in which the SARS-CoV-2 coronavirus gene is integrated.

Dr. Alexander Leonidovich Gintsburg is a Russian microbiologist. Since 1997, he has been the director of the Gamaleya Research Institute of Epidemiology and Microbiology.