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Tag: Johnson & Johnson

  • Nigeria to receive 29.8 million doses of Johnson & Johnson COVID-19 vaccine

    Nigeria to receive 29.8 million doses of Johnson & Johnson COVID-19 vaccine

    The National Primary Health Care Development Agency (NPHCDA) says Nigeria will receive 29.8 million doses of Johnson and Johnson (J&J) COVID-19 vaccine.

    The NPHCDA Executive Director, Dr Faisal Shuaib made this public on Monday during the Presidential Steering Committee (PSC) briefing on COVID-19 in Abuja.

    “The Federal Government has signed off to receive up to 29.8 million doses of the Johnson and Johnson COVID-19 vaccines through the African Union platform,” he said.

    Shuaib said the country was also expecting deliveries of vaccines through the COVAX facility by the end of May or early June.

    ”By this time, the country would have completed the process of administering the second doses of the Oxford-AstraZeneca COVID-19 vaccines already on ground.

    “Having received 3.94 million doses of the Oxford-AstraZeneca vaccines in early March, Nigeria commenced vaccination beginning with healthcare workers,” he said.

    Meanwhile, the NPHCDA boss, said vaccination against COVID-19 was still ongoing in all states of the Federation.

    He said the country had vaccinated 1,175,285 eligible Nigerians as of April 26, adding that the figure represented 58.4 per cent of people eligible to receive the vaccines.

    “Our collaboration with health officials and other stakeholders at the national, state, LGA and community levels in the vaccination exercise has yielded substantial result,” the NPHCDA executive secretary said.

    Shauib said that the government was aware of the global scarcity of COVID-19 vaccines due to high demands.

    He said the scarcity would affect the remaining phases of the vaccination campaign in the country.

    “We are aware of the global scarcity of COVID-19 vaccines due to high demands especially in countries where vaccines are being produced.

    “We therefore anticipate a delay in vaccine supply to Nigeria which may also affect and impact the remaining phases of the vaccination campaign.,” he explained.

    The Federal Government plans to vaccinate 109 million people against COVID-19 virus over a period of two years.

    It reports that only eligible population from 18 years and above will be vaccinated in four phases.

    Meanwhile, the J&J COVID-19 single-dose vaccine is compatible with standard vaccine storage and distribution channels with ease of delivery to remote areas.

    The vaccine is estimated to remain stable for two years at -4°F (-20°C), and a maximum of three months at routine refrigeration temperatures of 36-46°F (2 to 8°C).

    The U.S. Centres for Disease Control and Prevention and the US Food and Drug Administration recently approved the suspension of administering the J&J vaccine over six reported U.S. cases of a “rare and severe” type of blood clot.

    According to a joint statement on Tuesday from Anne Schuchat, CDC Principal Deputy Director and Peter Marks, FDA’s Center for Biologics Evaluation and Research Director, the six cases occurred among women aged between 18 and 48, while symptoms occurred within six to 13 days after vaccination.

    The suspension was however lifted on the J&J COVID-19 vaccines after 10 days, but with a directive that a warning label should printed on it about the potential for extremely rare blood clots.

    The European regulators in April also linked similar, highly unusual blood clots to the AstraZeneca COVID-19 shot, but found the benefits of the drug outweighed any risks.

  • BREAKING: U.S. resumes use of Johnson & Johnson COVID-19 vaccine

    BREAKING: U.S. resumes use of Johnson & Johnson COVID-19 vaccine

    The United States of America (USA) will resume use of the Johnson & Johnson Coronavirus disease (COVID-19) vaccine, the the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have said.

    The announcement by the FDA and CDC followed a thorough safety review after blood clots were reported from the use of the vaccine, ending the recommended pause.

    “The FDA and CDC determined that the recommended pause regarding the use of the Janssen (Johnson & Johnson) COVID-19 Vaccine in the U.S. should be lifted and use of the vaccine should resume,” both agencies stated in a joint statement.

    Recall the pause was recommended after reports of six cases of a rare and severe type of blood clot in individuals following administration of the Janssen COVID-19 Vaccine.

    During the pause, medical and scientific teams at the FDA and CDC examined available data to assess the risk of thrombosis involving the cerebral venous sinuses, or CVST (large blood vessels in the brain), and other sites in the body (including but not limited to the large blood vessels of the abdomen and the veins of the legs) along with thrombocytopenia, or low blood platelet counts.

    The teams at FDA and CDC also conducted extensive outreach to providers and clinicians to ensure they were made aware of the potential for these adverse events and could properly manage and recognize these events due to the unique treatment required for these blood clots and low platelets, also known as thrombosis-thrombocytopenia syndrome (TTS).

    Following the thorough safety review, the two agencies determined that the use of the Janssen COVID-19 vaccine should be resumed in the United States and that the FDA and CDC have confidence that this vaccine is safe and effective in preventing COVID-19.

    “The FDA has determined that the available data show that the vaccine’s known and potential benefits outweigh its known and potential risks in individuals 18 years of age and older.

    “At this time, the available data suggest that the chance of TTS occurring is very low, but the FDA and CDC will remain vigilant in continuing to investigate this risk,” a statement by both agencies reads.

    Commenting on the development, Janet Woodcock, M.D., Acting FDA Commissioner said the recommended pause was an example of extensive safety monitoring.

    Woodcock further stated that the pause was lifted based on the FDA and CDC’s review of all available data and in consultation with medical experts and based on recommendations from the CDC’s Advisory Committee on Immunization Practices.

    “Safety is our top priority. This pause was an example of our extensive safety monitoring working as they were designed to work—identifying even these small number of cases.

    “We’ve lifted the pause based on the FDA and CDC’s review of all available data and in consultation with medical experts and based on recommendations from the CDC’s Advisory Committee on Immunization Practices.

    “We have concluded that the known and potential benefits of the Janssen COVID-19 Vaccine outweigh its known and potential risks in individuals 18 years of age and older. We are confident that this vaccine continues to meet our standards for safety, effectiveness and quality.

    “We recommend people with questions about which vaccine is right for them have those discussions with their health care provider,” the Acting FDA Commissioner said.

    Also commenting was CDC Director, Dr. Rochelle P. Walensky, who said health and safety are at the forefront of the decision to lift the pause.

    The CDC Director further explained that as more Americans are vaccinated, all signals would be closely watched.

    “Above all else, health and safety are at the forefront of our decisions. Our vaccine safety systems are working. We identified exceptionally rare events – out of millions of doses of the Janssen COVID-19 administered – and we paused to examine them more carefully.

    “As we always do, we will continue to watch all signals closely as more Americans are vaccinated. I continue to be encouraged by the growing body of real-world evidence that the authorized COVID-19 vaccines are safe and effective, and they protect people from disease, hospitalization, and death,” the CDC Director stated.

    TNG reports on April 13, the FDA and CDC announced that, out of more than 6.8 million doses administered, six reports of a rare and severe type of blood clot combined with low blood platelet levels occurring in people after receiving the Janssen COVID-19 Vaccine had been reported to VAERS.

    In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia).

    “Today, the agencies can confirm that a total of 15 cases of TTS have been reported to VAERS, including the original six reported cases. All of these cases occurred in women between the ages of 18 and 59, with a median age of 37 years. Reports indicated symptom onset between 6 and 15 days after vaccination,” the joint statement by FDA and CDC reads.

  • BREAKING: U.S. calls for immediate halt of COVID-19 vaccine use

    BREAKING: U.S. calls for immediate halt of COVID-19 vaccine use

    The United States of America (USA) has called for an immediate halt of the use of a Coronavirus disease (COVID-19) vaccine.

    TheNewsGuru.com (TNG) reports the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) made the call on Tuesday.

    Both the FDA and CDC in a joint statement called for a temporary suspension of the use of the single-dose Johnson & Johnson vaccine.

    FDA and CDC discovered six cases in the United States of a rare and severe type of blood clot that developed about two weeks after the vaccine was administered in these patients.

    The joint statement issued on Tuesday by CDC and FDA reads: “As of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen) vaccine have been administered in the U.S.

    “CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine.

    “In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia).

    “All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination.

    “Treatment of this specific type of blood clot is different from the treatment that might typically be administered. Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given.

    “CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance.

    “FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution.

    “This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.

    “Right now, these adverse events appear to be extremely rare. COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously”.

  • South Africa settles for U.S. COVID-19 vaccine brand after rejecting UK’s AstraZeneca

    South Africa settles for U.S. COVID-19 vaccine brand after rejecting UK’s AstraZeneca

    South Africa will proceed with the planned coronavirus immunisation campaign using Johnson & Johnson vaccines instead of Oxford/AstraZeneca’s, which is deemed ineffective against the South African COVID-19 variant.

    The country’s Health Minister, Zwelini Mkhize said on Wednesday.

    TheNewsGuru.com, TNG reports that that on Monday, South Africa stopped the AstraZeneca vaccines rollout after a study published by the Wits Vaccines and Infectious Diseases Analytics Research Unit.

    The unit said that it showed that the vaccines offered minimal protection against mild-to-moderate forms of COVID-19 caused by the mutated coronavirus strain known as B.1.351, which was originally identified in South Africa in November.

    “`It is as a result of this work, in which the government had directly invested that it was established that the AstraZeneca vaccines does not prevent mild to moderate disease of the 501Y.V2 variant.

    “Given the outcomes of the efficacy studies, the Department of Health will continue with the planned phase 1 vaccination using the Johnson & Johnson vaccines instead of the AstraZeneca vaccines,’’ Mkhize said in a statement.

    According to the country’s health authorities, the Johnson & Johnson vaccines have been proven effective against the 501Y.V2 variant.

    The U.S-made vaccines will be used to inaugurate phase one of the mass vaccination campaign, in which South Africa’s 1.25 million health workers will be inoculated first.

    In late January, Johnson & Johnson said that its vaccine candidate was 66 per cent effective in preventing moderate to severe cases of COVID-19.

    The vaccine proved to be 85 per cent effective in preventing severe disease and provided complete protection against hospitalisation and death 28 days after the shot.

    Earlier, the company applied for the vaccine’s authorisation in the United States.