Search API
A biopharmaceutical company based in Pennsylvania focused on developing a vaccine to save lives from COVID-19 announced that it had selected Jubilant HollisterStier of Spokane, Washington as its manufacturing partner for the Covaxin™ vaccine to prepare for potential commercial manufacturing for the US and Canadian markets.
Covaxin is a highly purified and inactivated vaccine developed in collaboration with the Indian Council of Medical Research and Bharat Biotech manufactured using a vero cell manufacturing platform.
Covaxin is currently authorized in thirteen countries.
J.P. Gabriel, Ocugen, Inc.’s Senior Vice President, Manufacturing and Supply Chain, stated in a press release, “Securing US-based manufacturing capability is a critical step as we prepare to submit our regulatory submissions to the U.S. FDA and Health Canada. Based on Bharat Biotech’s strong track record of developing and commercializing vaccines globally and Jubilant’s proven track record in manufacturing, we are well-prepared to transition US manufacturing of COVAXIN to our new partner.”
Covaxin clinical studies show potential effectiveness against three key variants of SARS-CoV-2. In addition, these studies suggest that COVAXIN vaccination may be effective against multiple SARS-CoV-2 variants.
Ocugen, Inc. and India-based Bharat Biotech announced on February 2, 2021, a definitive agreement to commercialize Covaxin in the USA, with a later agreement expansion for the Canadian market.
The Ministry of Public Health of Afghanistan confirmed the third national polio immunization campaign would run from 14 to 17 June 2021. The campaign aims to reach approximately 9.9 million children under the age of 5 across the country with polio vaccines and Albendazole deworming tablets.
The polio program has intensified efforts to eradicate both wild poliovirus type 1 (WPV1) and circulating vaccine-derived poliovirus type 2 (cVDPV2) outbreaks, which were exacerbated due to disruptions to polio campaigns because of the COVID-19 pandemic.
So far, WPV1 and cVDPV2 outbreaks have been contained in all accessible areas of the country.
However, poliovirus transmission continues in certain areas where bans on house-house vaccination persist, leaving millions of children vulnerable due to the program’s inability to reach them for extended periods of time.
“It is extremely concerning that over 3.3 million children will yet again miss polio vaccination in certain areas of the country,” commented Dr. Wahid Majrooh, the acting Minister of Public Health. “Polio eradication is a collective responsibility. I strongly urge all parties to allow unimpeded access to reach children with critical vaccinations and other essential services.”
Vaccinating every child through multiple doses of the polio vaccine is the only way to stop the poliovirus currently circulating in the country. However, since the beginning of 2021, one WPV1 and 40 cVDPV2 cases have been confirmed in Afghanistan. All of them originate in areas where the campaign has been unable to access children for immunization.
In the USA, the inactivated polio vaccine is most often given in the USA since 2000. It is administered by a shot in the arm or leg, depending on the person’s age, says the U.S. CDC.
The IPOL vaccine is a sterile suspension of three types of poliovirus: Type 1 (Mahoney), Type 2 (MEF-1), and Type 3 (Saukett). It is a highly purified, inactivated poliovirus vaccine with enhanced potency administered intramuscularly or subcutaneously.
Ethiopian health officials launched an oral cholera vaccination campaign targeting 2 million people children in the Tigray region to avert a potential outbreak. Coverage with a full two-round dose of oral cholera vaccine provides up to five-year protection.
“The oral cholera vaccine is one of the proven preventive measures that can help avert needless sickness and death if done promptly,” said Dr. Boureima Hama Sambo, WHO Representative in Ethiopia, in a press statement.
The cholera vaccination drive began on June 10, 2021, is being carried out alongside measures such as the provision of water purification tablets and handwashing soaps to improve water, sanitation, and hygiene.
The Ethiopian Public Health Institute (EPHI) and the Tigray Regional Health Bureau lead the campaign, with logistical support from the Ethiopian Pharmaceutical Supply Agency and technical and operational support from World Health Organization (WHO) and partner organizations.
“In addition to the WHO’s role in the procurement and deployment of the vaccine doses, WHO teams have been working with our teams providing technical, operational, and logistical support. I commend the unreserved support and look forward to our continued partnership to ensure the health and safety of the people of Tigray, one of Ethiopia’s regions prone to seasonal cholera outbreaks,” commented Dr. Fasika Amdeselassie, head of the Tigray Health Bureau.
The Federal Democratic Republic of Ethiopia is located within the tropical latitudes and is relatively compact, with similar north-south and east-west dimensions. Ethiopia is the largest and most populated (~117 million) country in the Horn of Africa.
Cholera is a highly contagious disease transmitted through contaminated water or food. It causes severe diarrhea and dehydration that must be treated immediately to prevent death, which can occur in just a few hours, and to prevent the disease from spreading on a large scale in a high-risk environment, says the WHO.
The U.S. FDA recently approved a single-dose live oral cholera vaccine called Vaxchora®. The CDC's Advisory Committee on Immunization Practices voted to approve the vaccine for adults 18 – 64 years old who are traveling to an area of active cholera transmission.
According to the US Centers for Disease Control and Prevention (CDC), following the 2005 WHO's resolution, Europe could soon eliminate Rubella, a disease that causes miscarriages or serious congenital disabilities in a developing baby when a pregnant woman is infected.
The CDC confirmed in an MMWR issued on June 11, 2021, the estimated coverage with the first dose of a rubella-containing vaccine (RCV1) in the European Region (EUR) was 60% in 2000. That year, 621,039 rubella cases were reported, with an incidence of 716.9 cases per 1 million population.
However, EUR's rubella coverage with the first and second doses of RCVs significantly improved over the past 10 years.
By 2019, thirty-one countries reported significant progress and achieved ≥95% RCV1 coverage. Moreover, the rubella incidence declined to 0.7 cases per 1 million population by 2019.
This vaccination progress would make EUR the second WHO region to achieve rubella elimination, the first being the Region of the Americas.
Rubella can be prevented with the MMR vaccine. This protects against three diseases: measles, mumps, and rubella.
The CDC recommends children get two doses of MMR vaccine, starting with the first dose at 12 through 15 months of age and the second dose at 4 through 6 years of age. Teens and adults should also be up to date on their MMR vaccination.
And the CDC says the 'MMR vaccine is very safe and effective.'
In the USA, the M-M-R-II vaccine is often available at healthcare provider clinics or pharmacies.
On June 11, 2021, the US Centers for Disease Control and Prevention (CDC) reissued Level 2 Travel Alerts for Africa and Asia regarding polio outbreaks in various countries.
Since 2000, the inactivated polio vaccine is most often given in the USA. It is administered by a shot in the arm or leg, depending on the person’s age, says the U.S. CDC. The oral polio vaccine is offered in other countries.
The CDC recommends that children get polio vaccinated to protect against poliomyelitis. The CDC's Advisory Committee on Immunization Practices Vaccine Recommendations is published on this webpage.
The WHO recently reported 1,226 polio cases of all forms were confirmed in 2020, compared to 138 in 2018.
On June 10, 2021, the Global Polio Eradication Initiative announced the Polio Eradication Strategy 2022-2026: Delivering on a Promise at a virtual event to overcome the remaining challenges to ending polio.
While polio cases have fallen 99.9% since 1988, polio remains a WHO Public Health Emergency of International Concern, and persistent barriers to reaching every child with polio vaccines and the pandemic have contributed to an increase in polio cases.
This strategy includes deploying proven tactics used against wild polio, improving outbreak response and streamlining management through the launch of new global and regional rapid response teams and broadening the use of a promising new tool – novel oral polio vaccine type 2 (nOPV2) – to combat type 2 cVDPVs, the most prominent variant.
Select countries began using nOPV2 in March of this year after WHO issued an Emergency Use Listing recommendation for the vaccine in November 2020. Clinical trials have shown that nOPV2 is safe and effective against type 2 polio while having the potential to stop cVDPV2 outbreaks more sustainably compared to the existing type 2 oral polio vaccine.
H.E. Félix Tshisekedi, President of the Democratic Republic of the Congo, said in a press statement, “As Chair of the African Union, I call on every government to increase their commitment to protecting the gains of our monumental efforts and finishing the job against polio in Africa. Only then we will be able to say we delivered on our promise of a safer, healthier future for all our children.”
The Global Polio Eradication Initiative (GPEI) recently launched the Polio Eradication Strategy 2022-2026: Delivering on a Promise at a virtual event to overcome the remaining challenges to ending polio.
While polio cases have fallen 99.9% since 1988, polio remains a Public Health Emergency of International Concern, and persistent barriers to reaching every child with polio vaccines and the pandemic have contributed to an increase in polio cases.
During 2020, there were over 1,200 cases of all forms of polio recorded compared to just 138 in 2018, according to the WHO.
On June 10, 2021, leaders from the two countries yet to interrupt wild polio transmission, Pakistan and Afghanistan, called for renewed global solidarity and the continued resources necessary to eradicate this vaccine-preventable disease.
Since 2000, the inactivated polio vaccine is most often given in the USA. It is administered by a shot in the arm or leg, depending on the person’s age, says the U.S. CDC.
The CDC recommends that children get polio vaccinated to protect against poliomyelitis. The CDC's Advisory Committee on Immunization Practices Vaccine Recommendations is published on this webpage.
On June 11, 2021, the CDC issued Level 2 Travel Alerts for Africa and Asia regarding active polio outbreaks.
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.
Denmark-based Bavarian Nordic A/S announced today that the Company was recently engaged by Public Health England (PHE) and the Medicines and Health Products Regulatory Agency to supply IMVANEX® smallpox vaccine in response to new cases of monkeypox in the UK.
Two related cases were admitted to a hospital in Liverpool, England.
One was most likely infected in Africa, where the family arrived from a few days before the onset of disease, and a sibling case most likely infected on UK soil by the first case.
Monkeypox is a rare but serious disease, which is endemic in Central and West Africa. Although it is less severe with an estimated fatality rate of up to 10%, the disease is quite similar to human smallpox, says PHE.
Paul Chaplin, President and CEO of Bavarian Nordic, commented in a press statement, “We are pleased to assist PHE rapidly in such an emergency. Vaccination is a critical measure to prevent and control the spread of diseases globally. Governments have an essential role in preparing for outbreaks by stockpiling vaccines and treatments so that they are readily available in events like this."
Bavarian Nordic previously delivered IMVANEX to PHE in connection with the first human cases of monkeypox in the UK in 2018 and later in 2019.
IMVANEX (MVA-BN) is approved by the European Commission for active immunization against smallpox and has also received approval for monkeypox by the U.S. Food and Drug Administration (JYNNEOS) and Health Canada, the only vaccine approved for this indication in these territories.
On May 7, 2021, Bavarian Nordic confirmed the U.S. Biomedical Advanced Research and Development Authority had exercised the final $12 million option under the $202 million order for JYNNEOS awarded in April 2020.
Bavarian Nordic (OMX: BAVA) is a fully integrated vaccines company focused on developing, manufacturing, and commercializing life-saving vaccines.
The European Parliament gave final approval for the Digital COVID-19 vaccine certificate on June 9, 2021. European Union citizens can use this app to travel freely among European countries without quarantining or undergoing extra tests.
The program is expected to begin July 1, 2021
Individual nations will issue vaccine certificates, and all EU countries must recognize certificates issued by other EU countries. And personal data will not be shared with other countries.
Several countries have already begun introducing the system, including Bulgaria, Croatia, the Czech Republic, Denmark, Germany, Greece, and Poland.
In a press release, the European Parliament stated, 'all EU countries must accept vaccination certificates issued in other member states for vaccines authorized by the European Medicines Agency. Member states can decide to accept other vaccine certificates.
