Coronavirus Breaking News

The U.S. CDC confirmed on September 10, 2021, although most people with COVID-19 get better within the weeks following illness, some people experience post COVID-19 conditions.

A recent CDC study shows that adults with COVID-19 may experience ongoing health problems that can last four or more weeks after SARS-CoV-2 betacoronavirus infection.

These health problems may include shortness of breath, fatigue, difficulty concentrating (“brain fog”), headache, fast-beating or pounding heart, cough, joint or muscle pain, dizziness/lightheadedness, or mood changes, among other symptoms.

Even people who did not have significant COVID-19 symptoms days or weeks after they were infected can have post-COVID conditions.

The best way to prevent post-COVID conditions is by getting vaccinated against COVID-19 as soon as you can, says the CDC.

Furthermore, the COVID-19 vaccines recommended for use in the USA continue to offer protection against severe illness, hospitalization, and death.

To find a vaccine provider near you, visit Vaccines.gov or a local pharmacy.

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) announced its Authorization for a third booster dose of a COVID-19 vaccine today.

In a press release issued on September 9, 2021, Dr. June Raine, MHRA Chief Executive, said, 'We are committed to getting safe and effective COVID-19 vaccines to the UK public. This means ensuring that existing COVID-19 vaccines can continue to be used in the most effective way possible.'

'We know that a person’s immunity may decline over time after their first vaccine course.'

'I am pleased to confirm that the COVID-19 vaccines made by Pfizer-BioNTech (Comirnaty) and AstraZeneca (Vaxzevria) can be used as safe and effective booster doses.'

'It will now be for the Joint Committee on Vaccination and Immunisation (JVCI) to advise on whether booster jabs will be given and, if so, which vaccines should be used.'

The JVCI recently published two updates during September 2021:

• JCVI issued updated advice on September 3, 2021, regarding COVID-19 vaccination of children aged 12 to 15.
• The JCVI advised on September 1, 2021, that people with severely weakened immune systems should have a third vaccine dose as part of their primary COVID-19 vaccination schedule.

Additionally, the NHRA says the 'current supply of the COVID-19 vaccines made by Pfizer and AstraZeneca has been authorized on an emergency use basis. Both vaccines are also authorized under Conditional Marketing Authorisations (CMAs), but changes to these would follow a different procedure.

Vaccines covered by CMAs can also be used as part of deployment programs via “off-label” use under a prescriber’s direction.

Cuba began vaccinating children as young as 2 years of age on September 5, 2021, with a locally developed COVID-19 vaccine not recognized by the World Health Organization, reported Voice of America.

Cuba is administering the Soberana-2 COVID-19 vaccine, which was approved for this age group by local regulators on September 3, 2021.

On June 14, 2021, the first adolescents in the clinical trial were carried out at the Juan Manuel Márquez Pediatric Hospital, the Carlos J. Finlay polyclinic in the Marianao municipality, and the 5 de Septiembre polyclinic in the Playa municipality in the province of Havana.

All 350 children included in the trial received both doses of SOBERANA-02. In addition, all children in the subgroup 12 to 18 years old have already received the booster dose with SOBERANA-Plus.

This study's results showed that the SOBERANA-02 vaccine was safe for its administration in children and adolescents.

Based on the Phase I / II trial results in pediatric ages with SOBERANA-02, Cuba's Center for State Control of Medicines, Equipment, and Medical Devices was requested on August 27th to extend emergency use authorization for emergency use a population between 3 and 18 years of age.

Furthermore, the effect of the booster (3rd) vaccine dose with SOBERANA-Plus was summarized only for adolescents in Phase I of the trial. A significant increase in the values ​​was detected after the 3rd vaccine dose with all the immunological variables.

The Soberana 02 vaccine has been in human clinical trials since October 30, 2020. Soberana 02 is produced by the Finlay Vaccine Institute (IFV), a Cuban epidemiological research institute, and the Pasteur Institute of Iran. The IFV was created in 1991.

The European Medicines Agency (EMA) confirmed on September 6, 2021, it has started evaluating an application for the use of a booster (3rd) dose of the mRNA Comirnaty (Pfizer - BioNTech) vaccine to be given 6 months after the second dose in people aged 16 years and older.

The EMA’s committee will carry out an accelerated assessment of data submitted by the company that markets Comirnaty, BioNTech Manufacturing GmbH, including results from an ongoing clinical trial in which around 300 adults with healthy immune systems received a booster (3rd) dose approximately 6 months after the second dose.

While these evaluations are ongoing, the EMA and the European Centre for Disease Prevention and Control (ECDC) have highlighted their current position on September 2nd regarding the need for additional and booster doses of COVID-19 vaccines in a separate communication.

'It is important to distinguish between booster doses for people with normal immune systems and additional doses for those with weakened immune systems.'

Although the EMA and ECDC do not consider the need for COVID-19 vaccine booster doses to be urgent in the general population, the EMA is evaluating the present application to ensure evidence is available to support further doses as necessary.

The European Medicines Agency is a decentralized agency of the European Union (EU) responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the EU. An independent Management Board governs EMA.

Publishing as a non-peer-reviewed preprint study on August 25, 2021, researchers led by Tal Patalon and Sivan Gazit at Maccabi Healthcare Services in Tel Aviv, Israel, analyzed a healthcare database containing information about 2.5 million Israelis.

They examined new SARS-CoV-2 betacoronavirus infections in people who had never been infected but had been vaccinated with the mRNA Comirnaty (Pfizer - BioNTech) vaccine, and those who were not yet vaccinated but had recovered from COVID-19, and in people who had received one dose of Comirnaty and had also previously had COVID-19.

These researchers found that Israelis who had never been infected and were vaccinated in January and February were 6-13 times more likely to become infected during June – August 2021, when the Delta variant was the dominant strain circulating in Israel unvaccinated people who had recovered from SARS-CoV-2.

They also compared two groups of 14,000 unvaccinated people who had recovered from SARS-CoV-2 with a similarly sized group of people who had previously been infected and had received one dose of the Comirnaty vaccine.

The research team found that the previously infected but unvaccinated group was 2x as likely to be reinfected as those previously infected and received one dose of the Comirnaty vaccine.

The study indicates that the natural immunity gained through becoming infected and recovering from SARS-CoV-2 is of great value in protecting against future disease.

Moreover, this protection is further enhanced when combined with COVID-19 vaccination.

'It’s important to note that although natural immunity can be highly protective, it can come at a great cost – millions haven’t survived COVID-19, and others have suffered severe disease and hospitalization, said GAVI in a statement issued on August 31, 2021.

The Pan American Health Organization (PAHO) launched a new platform on September 1, 2021, to ease the severe shortage of COVID-19 vaccines in Latin America and the Caribbean.

So far, about 23% of people in the PAHO region have been fully COVID-19 vaccinated, and coverage is much lower in many countries.

During a recent virtual meeting, PAHO Director Carissa F. Etienne announced the Regional Platform to Advance the Manufacturing of COVID-19 Vaccines and other Health Technologies in the Americas.”

She described it as an initiative that will “coordinate across sectors – health, science and technology, and industry - to strengthen their capacity to produce new technologies.”

Explaining the need for the platform, Dr. Etienne added, “limited (global) production and unequal distribution of vaccines in the face of staggering demand hinder our COVID response."

"Mass vaccination is critical if we are to stem the tide of this pandemic and hinder the spread of further variants.”

“Vaccination rates remain in the teens in several Caribbean and South American countries, and coverage is still in the single digits in Central American nations like Guatemala, Honduras, and Nicaragua,” she continued.

Dr. Etienne said that in total, 540 million COVID-19 vaccine doses must be delivered to ensure that all countries in Latin America and the Caribbean can cover at least 60% of their populations.

“So we must expand vaccine access in our region, especially in the places that are lagging,” she said.

The first initiative under the platform is to facilitate the transfer to the region of the mRNA vaccine technology used in highly effective COVID-19 vaccines. The PAHO has received 32 proposals from private and public companies that want to participate in the endeavor.

The platform will support collaboration across countries and cooperation agencies, applying existing regional biomanufacturing capacity to the production of COVID-19 vaccines and other medical technologies. The principle is that manufacture should benefit the entire region, with regional pharmaceutical production and distribution of the vaccines by PAHO’s Revolving Fund to all countries.

The European Medicines Agency (EMA) safety committee (PRAC) announced today it is assessing whether there is a risk of the multisystem inflammatory syndrome (MIS) with COVID-19 vaccines.

As of August 19, 2021, MIS cases reported in children and adults from the EudraVigilance database were: Comirnaty: 5; Spikevax: 1; COVID-19 Vaccine Janssen: 1.

At this stage, there is no change to the current EU recommendations for the use of COVID-19 vaccines, says the EMA.

MIS is a rare but serious inflammatory condition affecting many parts of the body. Symptoms can include tiredness, persistent severe fever, diarrhea, vomiting, stomach pain, headache, chest pain, and difficulty breathing, says the U.S. CDC.

The PRAC's announcement confirmed it would assess the available data on MIS to determine whether the condition can be caused by the vaccine and recommend whether any changes to the product information of the vaccines are needed.